N/A
N=128
Inflammation and the Heart
Rheumatoid Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT01589770 ↗Enrolled (actual)
128
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: Left Ventricular Mass Indexed to BSA, g/m^2 — 43.8; 42.2 g/m^2
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- cardiac Magnetic Resonance imaging (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Left Ventricular Mass Indexed to BSA, g/m^2 |
43.8; 42.2 | — |
| SECONDARY Left Atrium Size, mm |
29; 29 | — |
Summary
Studies have shown that people with rheumatoid arthritis (RA) have a higher rate of heart disease than people that do not have RA. we believe this is caused by the inflammation produced by RA.
Eligibility Criteria
Inclusion Criteria
- Written informed consent
- Age >= 18
- RA only: meet American College of Rheumatology(ACR)criteria for Diagnosis of RA
- Controls only: no evidence of RA or other inflammatory disease
Exclusion Criteria
- Previous or current heart failure or ischemic cardiovascular disease (eg stroke, myocardial infarction, angina, CABG, stent).
- Atrial fibrillation.
- Known structural or functional cardiac abnormality, including pulmonary htn.
- Glomerular filtration rate < 60 ml/min.
- Pregnancy or breastfeeding.
- Unable to perform MRI (claustrophobia, unable to fit in magnet,pacemaker,defibrillator or non-MR safe implant).
- Hypersensitivity to gadolinium.
Data sourced from ClinicalTrials.gov (NCT01589770). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.