Myocardial Inflammation in Rheumatoid Arthritis: A Descriptive Study

Sponsor

Mayo Clinic (Other)

Overall Status

Recruiting

CT.gov ID

NCT03776682

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Inflammation Rheumatoid Arthritis Coronary Artery Disease Myocardial Strain

Study Design

Study Type:

Observational

Anticipated Enrollment :

40 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Myocardial Inflammation in Rheumatoid Arthritis: A Descriptive Study

Actual Study Start Date :

Jun 22, 2018

Anticipated Primary Completion Date :

Jun 21, 2023

Anticipated Study Completion Date :

Jun 21, 2023

Arms and Interventions

Arm	Intervention/Treatment
Acute inflammation Patients with RA and active inflammation (by exam or inflammatory markers)
Chronic remission Patients with RA who are in remission (clinically)

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

Diagnosis of Rheumatoid Arthritis according to 2010 American College of Rheumatology (ACR) criteria (14)
RA disease duration ≤ 10 years since diagnosis
CDAI Score of either ≤ 2.8 (low disease activity) or >10 (moderate to high disease activity)
≥ 40 years of age
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
Relevant lung disease (including COPD, 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
Ejection fraction (EF) less than 45%
Life expectancy < 1 year
BMI >35kg/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