Myocardial Inflammation in Rheumatoid Arthritis: A Descriptive Study

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.

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Key information

Conditions

Myocardial Inflammation Arterial Occlusive Diseases Arteriosclerosis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Cardiomyopathies Cardiovascular Diseases Connective Tissue Diseases Coronary Artery Disease Coronary Disease Heart Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Myocardial Ischemia Myocardial Strain Myocarditis Rheumatic Diseases Rheumatoid Arthritis Skin and Connective Tissue Diseases Vascular Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Subclinical myocardial inflammatory burden as detected by PET imaging

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start: 2018
Primary completion: 2023
Study completion: 2023
First posted: Dec 17, 2018
Registry last updated: Jul 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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