Inflammation and the Heart

NCT01589770 | Completed Results

• 1 other identifier: 120314
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid arthritis; inflammation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Left Atrium Size, mm

  one scan, cross sectional comparison

Study Arms (2)

rheumatoid arthritis patients

OTHER

People who have rheumatoid arthritis underwent cMRI

Other: cardiac Magnetic Resonance imaging

controls

OTHER

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

Other: cardiac Magnetic Resonance imaging

Interventions

cardiac Magnetic Resonance imaging OTHER

controls; rheumatoid arthritis patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University: lead
• Arthritis Foundation: collaborator

Study Sites (1)

Vanderbilt

Nashville, Tennessee, 37232, United States

Location

Related 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 Activity. J Rheumatol. 2018 Aug;45(8):1078-1084. doi: 10.3899/jrheum.170770. Epub 2018 Apr 15.

  PMID: 29657146 RESULT

MeSH Terms

Conditions

Arthritis, Rheumatoid; Inflammation

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Study is cross-sectional. Rheumatoid arthritis patients had low to moderate disease activity.

Results Point of Contact

• Title: Dr. C. M. Stein
• Organization: Vanderbilt University Medical Center

michael.stein@vanderbilt.edu

615-936-3420

Study Officials

• Charles Michael Stein, MD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Individuals specialized in cMRI performed the analyses and were blinded to disease status of participants.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dan May Professor of Medicine, Professor of Pharmacology, Assistant Director of the Division of Clinical Pharmacology

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

Study Record Dates

• First Submitted: April 24, 2012
• First Posted: May 2, 2012
• Study Start: August 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: May 6, 2019
• Results First Posted: April 12, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: 6 months after publication
• Access Criteria: IPD will be shared on request made to the PI. Criteria: Data is not to be shared. Data should only be used for biomedical research. Researchers requesting access will need appropriate IRB approval and sign a data use agreement.

Locations

US (1)