Inflammation and the Heart

NCT ID: NCT01589770

Last Updated: 2019-05-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2015-01-31

Brief Summary

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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

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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.

Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

All participants underwent cardiac MRI(cMRI) using a 1.5 tesla Siemens Magnetom Avanto scanner to compare left ventricular structure and Left atrium size.
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors
Individuals specialized in cMRI performed the analyses and were blinded to disease status of participants.

Study Groups

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rheumatoid arthritis patients

People who have rheumatoid arthritis underwent cMRI

Group Type OTHER

cardiac Magnetic Resonance imaging

Intervention Type OTHER

controls

people who do not have RA or other inflammatory disease underwent cMRI

Group Type OTHER

cardiac Magnetic Resonance imaging

Intervention Type OTHER

Interventions

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cardiac Magnetic Resonance imaging

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Arthritis Foundation

OTHER

Sponsor Role collaborator

Vanderbilt University

OTHER

Sponsor Role lead

Responsible Party

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C. Michael Stein

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Charles Michael Stein, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Locations

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Vanderbilt

Nashville, Tennessee, United States

Site Status

Countries

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United States

References

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Bradham W, Ormseth MJ, Elumogo C, Palanisamy S, Liu CY, Lawson MA, Soslow JH, Kawel-Boehm N, Bluemke DA, Stein CM. Absence of Fibrosis and Inflammation by Cardiac Magnetic Resonance Imaging in Rheumatoid Arthritis Patients with Low to Moderate Disease Activity. J Rheumatol. 2018 Aug;45(8):1078-1084. doi: 10.3899/jrheum.170770. Epub 2018 Apr 15.

Reference Type RESULT
PMID: 29657146 (View on PubMed)

Other Identifiers

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120314

Identifier Type: -

Identifier Source: org_study_id

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