Inflammation and the Heart
This trial is active, not recruiting.
|Start date||August 2012|
|End date||December 2017|
|Trial size||345 participants|
|Trial identifier||NCT01589770, 120314|
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.
|Observational model||case control|
People who have rheumatoid arthritis
people who do not have RA or other inflammatory disease
change in myocardial size and contractility measured by MRI
time frame: before, and 6 months (24 weeks) after, starting disease modifying therapy
Male or female participants at least 18 years old.
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.
|Official title||Inflammation and the Heart|
|Principal investigator||Charles Michael Stein, MD|
|Description||Aim 1: We want to study people with RA to see if we can detect very early changes in their heart muscle and compare these results to people who do not have RA. Aim 2: We want to study people with RA, who have at least 4 swollen joints, before and 6 months after starting a disease modifying therapy to see if there are any changes in the heart muscle on treatment.|
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