Myocardial Inflammation in Rheumatoid Arthritis: A Descriptive Study

Coronary Artery Disease Clinical Trial

Official title:

Myocardial Inflammation in Rheumatoid Arthritis: A Descriptive Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03776682
• Other study ID #: 17-009867
• Status: Completed
• Start date: June 22, 2018
• Est. completion date: May 26, 2023

Study information

• Verified date: July 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: May 26, 2023
• Est. primary completion date: May 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Coronary Artery Disease
• Inflammation
• Myocardial Inflammation
• Myocardial Strain
• Myocarditis
• Rheumatoid Arthritis

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subclinical myocardial inflammatory burden as detected by PET imaging	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.	14 days
Primary	Relationship of presence of myocardial inflammation to atherosclerotic burden	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.	7 days

External Links

•   Mayo Clinic Clinical Trials