This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Inflammation and the Heart (NCT01589770), a non-randomized na study. The primary outcome is Left Ventricular Mass Indexed to BSA, g/m^2.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01589770 |
| Phase | NA |
| Condition | Rheumatoid Arthritis |
| Allocation | Non-Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 128 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Vanderbilt University |
| Results posted | Yes |
2. Clinical Question
Population
People with rheumatoid arthritis (RA) were compared with people who did not have RA or another inflammatory disease. The record describes the RA group as patients who underwent cardiac magnetic resonance imaging (cMRI), and the control group as people without RA or other inflammatory disease who underwent cMRI.
Intervention
The listed intervention is cardiac Magnetic Resonance imaging. The record describes a scan in each group; it does not describe an assigned treatment intended to alter inflammation or cardiac mass.
Comparator
The comparator is the control group without RA or other inflammatory disease. Because allocation was nonrandomized, the groups should not be treated as exchangeable by design. Characteristics that might differ between the groups are not reported in the registry record.
Primary question
The primary outcome is left ventricular mass indexed to body surface area (BSA), reported in g/m^2. The intended question is how this measure compares between the RA and control groups in a one-scan, cross-sectional comparison. The registry record does not report the group medians, inter-quartile ranges, an estimated contrast, or a statistical test result, so it does not establish what the comparison found.
3. Trial Design
Inflammation and the Heart (NCT01589770) is recorded as a completed, nonrandomized, parallel study sponsored by Vanderbilt University. The listed condition is rheumatoid arthritis. The record gives an enrollment of 128 and identifies the study phase as NA. The study start is recorded as 2012-08 and primary completion as 2015-01.
The comparison is observational in its allocation: people with RA and controls were assessed rather than randomly assigned to those groups. The listed model is parallel, and masking is recorded as single. The identity of the masked party and the procedures used to maintain masking are not reported in the registry record. The record describes cardiac Magnetic Resonance imaging as the intervention, with both groups undergoing cMRI.
The primary outcome is left ventricular mass indexed to BSA, with a one-scan cross-sectional comparison as its timeframe. Left atrium size, measured in mm, is listed as a secondary outcome. Although two outcome measures are recorded, no outcome analysis is listed. The outcome-specific results and analysis populations are not reported in the registry record.
Nonrandomized comparisons can describe differences between groups, but group membership may also be related to other characteristics that affect the measured outcome. Random allocation is not part of this study design, so it cannot ensure balance in such characteristics. The registry record does not report whether or how potential confounding was addressed. These design features matter when interpreting any group contrast: a difference would be an observed association in the study groups, not by itself evidence that RA caused that difference.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Rheumatoid Arthritis Patients | Controls |
|---|---|---|
| STARTED | 67 | 61 |
| COMPLETED | 59 | 56 |
| NOT COMPLETED | 8 | 5 |
Reasons for not completing this period:
| Reason | Rheumatoid Arthritis Patients | Controls |
|---|---|---|
| EGFR <60ml/min | 6 | 4 |
| claustrophobic when entering cardiac MRI | 2 | 1 |
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Rheumatoid Arthritis Patients | Controls | Total |
|---|---|---|---|---|
| Participants analysed | 59 | 56 | 115 | |
| Age, Continuous | years | 53 (40 to 59) | 52 (38 to 57) | 53 (38 to 59) |
| Sex: Female, Male: Female | Participants | 45 | 44 | 89 |
| Sex: Female, Male: Male | Participants | 14 | 12 | 26 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 1 | 1 | 2 |
| Race (NIH/OMB): White | Participants | 58 | 55 | 113 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Region of Enrollment: United States | participants | 59 | 56 | 115 |
6. Primary Endpoint
The registry lists the primary outcome as Left Ventricular Mass Indexed to BSA, g/m^2, measured over one scan, cross sectional comparison.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Inter-Quartile Range |
| Unit | g/m^2 |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is left ventricular mass indexed to body surface area, expressed in g/m^2. The record describes left ventricular mass as increasing in proportion to overall body size and as differing by gender. Dividing mass in grams by BSA is intended to adjust the measure for body size, making the indexed value more suitable for assessing how left ventricular mass relates to cardiovascular risk than unadjusted mass alone.
The record states that BSA was calculated from height in cm and weight in kg using the square root of height multiplied by weight divided by 3600. This describes how the index was formed; it does not report the actual values observed in either group. The endpoint is specified as a median with an inter-quartile range, a summary that describes the middle of the observed distribution and its spread. The registry record does not report the medians or inter-quartile ranges for the RA and control groups, or a numerical comparison between them.
As a general statistical point, indexing is useful when a measurement is expected to vary with body size, but it does not remove every possible source of group difference. The record does not report whether other characteristics were included in an adjusted analysis. The primary outcome is therefore interpretable as a specified body-size-indexed measure, while the extent to which the comparison accounts for other differences between groups is not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record specifies a comparison of median left ventricular mass indexed to BSA between people with RA and controls. It does not include the observed medians, inter-quartile ranges, a difference or other effect estimate, a confidence interval, or a p-value. It also lists zero analyses. Consequently, the direction and magnitude of the primary comparison cannot be determined from the registry record, and its statistical precision cannot be evaluated.
The enrollment entry is 128, but enrollment alone does not show how many participants contributed data to a particular outcome analysis. The adverse-event record lists 67 people at risk in the RA group and 61 in the control group; those safety entries do not establish the denominators used for the primary endpoint. Outcome-specific analysis counts are not reported in the registry record. The record also does not describe how incomplete scans or missing measurements were handled.
For a continuous measure, group medians and inter-quartile ranges would describe the distributions in each group. A contrast between groups would quantify the observed difference, while a confidence interval would communicate the range of values compatible with the data under the analysis assumptions. A p-value, if reported, would address compatibility with a specified null model; it would not measure the size or clinical importance of a difference. These are general explanations, not results reported for this study.
Even if a group difference were reported, the nonrandomized allocation would be important to its interpretation. Factors associated with both RA status and left ventricular mass could contribute to an observed contrast. The registry record does not report which covariates were measured or whether an adjusted comparison was conducted. A cross-sectional, one-scan comparison also does not establish how the measure changed over time or whether any difference preceded the disease status under study.
The record therefore supports description of the research question and design, but not a conclusion about the primary outcome. It does not provide results that could establish either a difference or the absence of a difference. An unreported result must not be read as a null finding. The same caution applies to the secondary outcome of left atrium size: it is listed, but its group results and analysis are not reported in the registry record.
9. Statistical Methods Explained
The endpoint is specified as a median and inter-quartile range. In general, a median identifies the central point of ordered observations, while the inter-quartile range describes the spread of the middle portion of a distribution. These summaries can be useful when a measure is not well represented by a mean and standard deviation or when the analysis is intended to emphasize the distribution's center and spread. The registry record does not explain why these summaries were selected, and does not provide the observed summaries.
The primary measure is left ventricular mass divided by BSA. In general, indexing a measurement to body size aims to reduce the influence of body-size differences on comparisons. The study description notes that left ventricular mass varies with overall body size and differs by gender, and gives a BSA formula based on height and weight. Indexing should not be mistaken for full adjustment for all relevant characteristics. The record does not report an adjusted model, covariates, or a method for accounting for gender or other group differences in the primary comparison.
The study is nonrandomized. In general, random allocation can help balance measured and unmeasured characteristics across study groups, whereas an observational group comparison may retain confounding. A confounder is a characteristic associated with both group membership and the outcome that can distort the apparent relationship between them. Statistical adjustment can address measured characteristics under appropriate assumptions, but cannot guarantee control of unmeasured differences. Whether adjustment was performed, and what assumptions it used, are not reported in the registry record.
The record describes a parallel design and a one-scan, cross-sectional comparison. In general, a cross-sectional measurement compares groups at a measurement occasion rather than estimating within-person change over time. It can describe an association at that occasion, but does not establish temporal order or change. The timing of each scan relative to RA history, disease activity, or other clinical factors is not reported in the registry record.
Masking is recorded as single, but the record does not identify who was masked or describe the masking procedures. In general, masking may reduce some forms of measurement or assessment bias when those involved in collecting or interpreting data are unaware of group assignment. The recorded label alone is not enough to determine how masking was implemented or whether it could affect the endpoint.
The registry record lists zero analyses. It does not report a statistical test, a model, an effect estimate, a confidence interval, or a p-value for either outcome. It also does not state whether the primary comparison was adjusted or how assumptions were checked. Thus, no study-specific inferential method can be attributed to the posted record beyond its description of the primary endpoint as a median with an inter-quartile range.
General statistical context: a confidence interval expresses uncertainty around an estimated quantity under a chosen analysis and its assumptions. Its width depends on factors including variability and the amount of outcome information available. Without a reported estimate, interval, and analysis denominator, the precision of this comparison cannot be judged. A confidence interval is not a guarantee that a particular value is correct, and its interpretation depends on the method used.
The record also states assumptions for planning illustrations based on the observed effect: a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation, with the target effect expressed as a stated fraction of the observed effect. These are planning assumptions, not evidence about the study's original design or its achieved power. The registry record does not report a sample-size justification, an interim analysis plan, or a statistical analysis plan. Any planning illustration based on an observed effect should not be described as observed power; it concerns hypothetical planning under stated assumptions.
General statistical context: over-dispersion occurs when the variation in data exceeds what a model assumes. If present, it can make uncertainty estimates too small when not handled appropriately. The registry record does not identify a count model or report over-dispersion, so this concept is not a study-specific finding. More generally, statistical methods should match the outcome scale and data structure, but the record does not supply enough analysis detail to assess those choices for this comparison.
The study has two listed outcome measures: the primary indexed left ventricular mass measure and the secondary left atrium size measure. Their presence does not reveal whether the investigators tested them, how they were ordered analytically, or how uncertainty from multiple comparisons was handled. Those analysis details are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists two outcome measures: left ventricular mass indexed to BSA as primary, and left atrium size in mm as secondary. It reports zero analyses. It does not state whether both outcomes were analyzed, whether other outcomes were considered, or whether any adjustment for multiple testing was used. The multiplicity plan is not reported in the registry record.
In general, testing multiple outcomes can increase the chance of a false-positive result if each is interpreted without regard to the others. Methods for addressing multiplicity depend on the number and role of the planned comparisons. No such method can be attributed to this study from the registry record. Since outcome results are also absent, there is no reported set of findings on which to assess multiplicity in practice.
Missing-data procedures and analysis populations are likewise not reported in the registry record. It does not state how many participants had usable cMRI measurements, whether any scans or endpoint values were unavailable, how missing values were handled, or which participants were included in each outcome analysis. The enrollment entry and the at-risk counts in the safety record do not substitute for endpoint-specific denominators.
In general, missingness can affect both the amount of information available and the interpretation of a comparison, particularly if the likelihood of missing data differs by group or is related to the outcome. The registry record does not provide enough information to determine whether missing data occurred or whether it could have affected the comparison. This is an absence of reporting, not evidence that missing data were present or absent.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Rheumatoid Arthritis Patients | 0 | 67 | 0.0% |
| Controls | 0 | 61 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Rheumatoid Arthritis Patients | 0 of 67 |
| Controls | 0 of 61 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Rheumatoid Arthritis Patients | 0 of 67 |
| Controls | 0 of 61 |
The adverse-event record lists 67 people at risk in the rheumatoid arthritis group and 61 in the control group. For each group, the recorded counts are zero for serious events, zero for other events, and zero deaths. These are the safety figures recorded for the groups; they are not results for the primary cardiac-mass endpoint.
Counts recorded as zero mean that the registry entry lists no events in those categories. They do not, by themselves, establish how safety events were defined, how actively they were sought, the duration of observation, or whether all participants had complete safety follow-up. Those details are not reported in the registry record. The at-risk counts should not be treated as the denominators for the primary outcome unless an outcome-specific analysis states that they were used; no such analysis is reported.
In general, an observed event count is interpreted in relation to the population under observation, the event definitions, and the completeness and duration of follow-up. A zero count is not proof that an event is impossible or that a risk is absent. The record does not provide additional detail that would support a broader safety conclusion.
12. What the Result Does, and Does Not, Mean
This study record identifies a question about left ventricular mass indexed to BSA in people with RA compared with controls without RA or other inflammatory disease. It also describes cMRI as the assessment and specifies a one-scan, cross-sectional comparison. These details establish what the registry record set out to compare, but they do not show the observed outcome.
The registry record does not report group medians, inter-quartile ranges, a between-group estimate, uncertainty intervals, or a statistical test. It therefore cannot show whether indexed left ventricular mass was higher, lower, or similar in the RA group, nor how precise any comparison was. The absence of a reported result is not evidence that the groups had the same values, and it is not evidence that a difference existed.
The nonrandomized design also limits causal interpretation. In general, group differences in characteristics other than RA status may influence an outcome comparison. Because the record does not report covariate adjustment or detailed group characteristics, it is not possible to determine how such differences were addressed. A cross-sectional measurement cannot establish the sequence of events or describe within-person change.
The record lists left atrium size as a secondary outcome, but reports no analysis of it. The safety entry lists zero serious events, zero other events, and zero deaths in each group, while not reporting the safety definitions or follow-up details. These entries should be read as registry-recorded counts rather than as a comprehensive evaluation of safety.
The study's statistical meaning is therefore primarily descriptive at the design level: it specifies a nonrandomized comparison and a body-size-indexed cardiac measure. It does not provide the results needed to characterize an association, evaluate its precision, or draw conclusions about its clinical importance. No treatment effect or medical recommendation follows from the information reported.
13. Why This Trial Matters Statistically
This study is statistically notable for asking a focused measurement question while using a nonrandomized comparison. The primary endpoint accounts for body size by indexing left ventricular mass to BSA, and the record gives the rationale and formula for that index. Such detail helps clarify what the endpoint represents and why the unindexed measurement was not the sole focus.
The design also illustrates why the type of comparison matters. In general, two groups may differ for reasons other than the condition used to define them. Nonrandomized allocation does not guarantee balance in those characteristics, and the registry record does not report whether an adjusted analysis addressed them. Interpretation of a group contrast would therefore require attention to both the endpoint and the comparability of the groups.
Equally important, the record does not report outcome results despite identifying a primary and a secondary measure. Without observed distributions, a contrast, and uncertainty estimates, readers cannot judge effect size or precision. Recognizing this boundary is a key statistical skill: a clearly specified endpoint is not itself evidence of an outcome, and an unreported analysis cannot be treated as a null result.
The record also separates safety counts from outcome information. Zero entries for event categories describe what the registry lists, but the lack of definitions and follow-up detail limits their interpretation. Overall, the statistical value of this record lies in clarifying the question, endpoint construction, and design constraints, while making clear that the posted information is insufficient to evaluate the cardiac measurement comparison.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The most direct limitation for interpreting this specific study is that the registry record does not report the primary or secondary outcome values or any analyses. There are no group medians or inter-quartile ranges for indexed left ventricular mass, no left atrium size results, and no reported effect estimates or measures of uncertainty. Thus, the central comparison cannot be evaluated from the posted results.
Although enrollment is recorded as 128, outcome-specific denominators and analysis populations are not reported. It is not possible to determine from this entry how many participants contributed usable measurements, whether any measurements were missing, or how missing observations were handled. The safety at-risk counts are not a substitute for the primary endpoint's analysis population.
The nonrandomized design means that differences between the RA and control groups may reflect factors other than RA status. The record does not provide detailed baseline characteristics or report an adjusted analysis, so the degree to which confounding was considered cannot be assessed. The cross-sectional, one-scan timeframe also does not provide information about change over time or temporal sequence.
The record does not identify who was masked despite recording single masking, and it does not describe the measurement or quality-control procedures for cMRI. Multiplicity handling for the two listed outcomes is not reported. The safety record does not define events or describe observation duration. These are limitations of what can be evaluated from the registry record; they do not establish that a particular bias, missing-data problem, or safety event occurred.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Inflammation and the Heart — NCT01589770.
- Registry record last updated 2019-05-06; status last verified 2019-04.
- Results first posted 2019-04-12.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
Inflammation and the Heart (NCT01589770) is recorded as a completed, nonrandomized, parallel study sponsored by Vanderbilt University, with an enrollment of 128. It lists rheumatoid arthritis as the condition and cardiac Magnetic Resonance imaging as the intervention. The study dates recorded are 2012-08 for start and 2015-01 for primary completion.
The primary outcome is median left ventricular mass indexed to BSA, with an inter-quartile range, assessed in a one-scan cross-sectional comparison. Left atrium size in mm is listed as a secondary outcome. The registry record lists zero analyses and does not report outcome results, analysis populations, or missing-data procedures. Safety entries list zero serious events, zero other events, and zero deaths in each group, without further follow-up detail.
The record therefore describes the study question and design but does not provide the results needed to assess the primary comparison or its precision.