Myocardial Inflammation in Rheumatoid Arthritis: A Descriptive Study

NCT ID: NCT03776682

Last Updated: 2023-07-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 35 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-06-22
• Study Completion Date: 2023-05-26

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.

Conditions

Myocardial Inflammation; Rheumatoid Arthritis; Coronary Artery Disease; Myocardial Strain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Acute inflammation

Patients with RA and active inflammation (by exam or inflammatory markers)

No interventions assigned to this group

Chronic remission

Patients with RA who are in remission (clinically)

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Diagnosis of Rheumatoid Arthritis according to 2010 American College of Rheumatology (ACR) criteria (14)
• RA disease duration ≤ 10 years since diagnosis
• Able to provide informed consent

Exclusion Criteria

• Known clinical atherosclerotic disease (myocardial infarction, severe obstruction CAD (≥ 1 untreated stenosis (≥ 70% in a major vessel) known by either invasive or noninvasive testing), prior coronary artery intervention, prior coronary artery bypass surgery, cerebrovascular event, peripheral vascular disease).
• Prednisone >10mg per day (or equivalent corticosteroid dose per day within last week)
• Irregular heart rhythm (arrhythmia or cardiac conduction abnormality (e.g. atrial fibrillation or flutter, frequent extrasystole, LBBB)
• Relevant valvular heart disease (> moderate regurgitation or stenosis of any heart valve)
• Clinical occurrence of heart failure with or without preserved ejection fraction
• Impaired imaging quality or other contraindications for myocardial strain imaging
• Relevant lung disease (including severe COPD with oxygen dependence, fibrosis, symptomatic pleural effusion, oxygen dependence)
• Sarcoidosis
• Diabetes mellitus treated with insulin
• estimated glomerular filtration rate (eGFR) < 40ml/min
• Known cancer
• History of any-type of cardiomyopathy (e.g. cardiac amyloidosis, hypertrophic cardiomyopathy,...)
• Ejection fraction (EF) less than 45%
• Life expectancy < 1 year
• BMI >40kg/m2
• Severe claustrophobia
• Any known allergic reactions to intravenous contrast
• Inability to receive beta blocker therapy or IV nitrates
• Pregnant/ Breastfeeding women
• Vulnerable persons due to Helsinki Declaration
• Unable to provide informed consent

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Rekha Mankad

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rekha Mankad, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

17-009867

Identifier Type: -

Identifier Source: org_study_id