Myocardial Inflammation in Rheumatoid Arthritis: A Descriptive Study

NCT03776682 | Completed

• 1 other identifier: 17-009867
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Acute inflammation

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

Chronic remission

Patients with RA who are in remission (clinically)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of 40 Patients with the diagnosis of RA, according to 2010 ACR classification, who are referred to the Mayo Clinic Department of Rheumatology outpatient clinic.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood is being stored for later biomarker assessment

MeSH Terms

Conditions

Myocarditis; Arthritis, Rheumatoid; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Rekha Mankad, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 11, 2018
• First Posted: December 17, 2018
• Study Start: June 22, 2018
• Primary Completion: May 26, 2023
• Study Completion: May 26, 2023
• Last Updated: July 10, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)