Inflammation and the Heart

Vanderbilt University1 site in 1 country128 target enrollmentAugust 2012

ConditionsRheumatoid Arthritis

Overview

Phase: N/A
Intervention: Not specified
Conditions: Rheumatoid Arthritis
Sponsor: Vanderbilt University
Enrollment: 128
Locations: 1
Primary Endpoint: Left Ventricular Mass Indexed to BSA, g/m^2
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2012

End Date

January 2015

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Vanderbilt University

Responsible Party

Principal Investigator

C. Michael Stein

Dan May Professor of Medicine, Professor of Pharmacology, Assistant Director of the Division of Clinical Pharmacology

Vanderbilt University

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.

Outcomes

Primary Outcomes

Left Ventricular Mass Indexed to BSA, g/m^2

Time Frame: 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).