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Inflammation and the Heart

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01589770
Recruitment Status : Active, not recruiting
First Posted : May 2, 2012
Last Update Posted : December 4, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Rheumatoid Arthritis

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.

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.


Study Design

Study Type : Observational
Estimated Enrollment : 345 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Inflammation and the Heart
Study Start Date : August 2012
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
rheumatoid arthritis patients
People who have rheumatoid arthritis
controls
people who do not have RA or other inflammatory disease


Outcome Measures

Primary Outcome Measures :
  1. change in myocardial size and contractility measured by MRI [ Time Frame: before, and 6 months (24 weeks) after, starting disease modifying therapy ]

    For RA patients, a baseline MRI study will be done before starting disease modifying therapy for RA. Starting therapy is decided by the patient's rheumatologist, so is standard of care. Six months (24 weeks) later a second MRI study will be done to see if treatment changes myocardial size and contractility.

    For controls, baseline study only will be done.



Biospecimen Retention:   Samples With DNA
serum plasma DNA RNA

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
people with rheumatoid arthritis and people without rheumatoid arthritis or other inflammatory disease
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01589770


Locations
United States, Tennessee
Vanderbilt
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Arthritis Foundation
Investigators
Principal Investigator: Charles Michael Stein, MD Vanderbilt University
More Information

Responsible Party: C. Michael Stein, Dan May Professor of Medicine, Professor of Pharmacology, Assistant Director of the Division of Clinical Pharmacology, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01589770     History of Changes
Other Study ID Numbers: 120314
First Posted: May 2, 2012    Key Record Dates
Last Update Posted: December 4, 2017
Last Verified: November 2017

Keywords provided by C. Michael Stein, Vanderbilt University:
rheumatoid arthritis
inflammation

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Inflammation
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes