Myocardial Inflammation in Rheumatoid Arthritis: A Descriptive Study

Completed

• Conditions: Rheumatoid Arthritis; Myocardial Inflammation; Coronary Artery Disease; Myocardial Strain

• Registration Number: NCT03776682
• Lead Sponsor: Mayo Clinic

Brief Summary

Rheumatoid arthritis (RA) patients have a higher prevalence of subclinical atherosclerosis than the general population. In addition, RA patients experience higher rates of heart failure with preserved ejection fraction (HFpEF). There is evidence that myocardial mechanics and left ventricular diastolic function are more abnormal in the RA population and these changes occur earlier than in the general population. Recently a study suggested that RA patient have abnormal myocardial inflammation during a disease flare and that this is improved with anti-inflammatory treatment. This study is aimed at describing the prevalence of myocardial inflammation in patients during active RA disease flares and comparing that with RA patients who are in remission. Investigators hope to show that abnormalities in myocardial inflammation on PET imaging correlate with abnormalities in myocardial strain on echocardiography. Coronary CT will be performed to establish the presence of subclinical atherosclerosis and whether its presence affects changes in either myocardial inflammation or myocardial strain. The hypothesis is that patients with evidence of myocardial inflammation during the course of their RA disease are more likely to develop HFpEF during their lifetime. Although the present study will not be of a duration to assess outcome, it will provide descriptive data which may help guide future prospective study of patients with RA which may help guide appropriate cardiovascular testing in this high risk population.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-22
• Study First Submitted: 2018-12-11
• Study First Submitted QC: 2018-12-13
• Study First Posted: 2018-12-17
• Primary Completion: 2023-05-26
• Study Completion: 2023-05-26
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-07
• Last Update Posted: 2023-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Subclinical myocardial inflammatory burden as detected by PET imaging	14 days	To determine if myocardial F-18 fluorodeoxyglucose (FDG) positron emission tomography (PET) imaging in patients with rheumatoid arthritis reveals evidence of subclinical myocardial inflammation which correlate with level of systemic inflammatory burden.
Relationship of presence of myocardial inflammation to atherosclerotic burden	7 days	To determine if mild to moderate atherosclerotic plaque burden on coronary computed tomographic angiography (CCTA) correlates with the degree of myocardial inflammation as assessed by FDG PET.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States