Inflammation and the Heart

Rheumatoid Arthritis Clinical Trial

Official title:

Inflammation and the Heart

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01589770
• Other study ID #: 120314
• Status: Completed
• Phase: N/A
• Start date: August 2012
• Est. completion date: January 2015

Study information

• Verified date: April 2019
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Inflammation
• Rheumatoid Arthritis

Intervention

Other:
• cardiac Magnetic Resonance imaging

Locations

Country	Name	City	State
United States	Vanderbilt	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	Arthritis Foundation

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 Act — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Left Ventricular Mass Indexed to BSA, g/m^2	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).	one scan, cross sectional comparison
Secondary	Left Atrium Size, mm	left atrium size, measured in millimeters	one scan, cross sectional comparison