Myocardial Inflammation in Rheumatoid Arthritis: A Descriptive Study

July 7, 2023 updated by: Rekha Mankad, Mayo Clinic
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
14 days
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.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Rekha Mankad, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 22, 2018

Primary Completion (Actual)

May 26, 2023

Study Completion (Actual)

May 26, 2023

Study Registration Dates

First Submitted

December 11, 2018

First Submitted That Met QC Criteria

December 13, 2018

First Posted (Actual)

December 17, 2018

Study Record Updates

Last Update Posted (Actual)

July 10, 2023

Last Update Submitted That Met QC Criteria

July 7, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-009867

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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