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OpenTrials
Completed

NCT Number: NCT01589770

Inflammation and the Heart

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Inflammation Joint Diseases Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt

Nashville, Tennessee, 37232, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cardiac Magnetic Resonance Imaging

Other

Primary outcomes

  1. 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).

Secondary outcomes

  1. Left Atrium Size, mm

    Time frame: one scan, cross sectional comparison

    left atrium size, measured in millimeters

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Collaborators

  • Arthritis Foundation

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
May 2, 2012
Registry last updated
May 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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