Inflammation and the Heart

Not Applicable

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Other: cardiac Magnetic Resonance imaging

• Registration Number: NCT01589770
• Lead Sponsor: Vanderbilt University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2012-04-24
• Study First Submitted QC: 2012-04-30
• Study First Posted: 2012-05-02
• Study Start: 2012-08
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Results First Submitted: 2019-01-11
• Results First Submitted QC: 2019-01-11
• Status Verified: 2019-04
• Results First Posted: 2019-04-12
• Last Update Submitted: 2019-04-23
• Last Update Posted: 2019-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
controls	cardiac Magnetic Resonance imaging	people who do not have RA or other inflammatory disease underwent cMRI
rheumatoid arthritis patients	cardiac Magnetic Resonance imaging	People who have rheumatoid arthritis underwent cMRI

Primary Outcome Measures

Name	Time	Method
Left Ventricular Mass Indexed to BSA, g/m^2	one scan, cross sectional comparison	Left Ventricular Mass (LVM) is known to increase in proportion to overall body size and differs by gender. To assess an individual's risk for a cardiovascular event based on LVM,an adjustment for the patient's body size should be done. LVM in grams was divided by body surface area in meters squared, to adjust for body size. Body surface area was calculated by square root (height (cm) X weight (kg)/3600).

Secondary Outcome Measures

Name	Time	Method
Left Atrium Size, mm	one scan, cross sectional comparison	left atrium size, measured in millimeters

Trial Locations

Locations (1)

Vanderbilt; 🇺🇸 Nashville, Tennessee, United States