Myocardial Inflammation in Rheumatoid Arthritis: A Descriptive Study

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT03776682
Collaborator
(none)
40
Enrollment
1
Location
47.9
Anticipated Duration (Months)
0.8
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.

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 18, 2022
Anticipated Study Completion Date :
Jun 18, 2022

Arms and Interventions

ArmIntervention/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

  1. 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.

  2. 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:
No

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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Mayo Clinic in RochesterRochesterMinnesotaUnited States55905

Sponsors and Collaborators

  • Mayo Clinic

Investigators

  • Principal Investigator: Rekha Mankad, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Rekha Mankad, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT03776682
Other Study ID Numbers:
  • 17-009867
First Posted:
Dec 17, 2018
Last Update Posted:
Jul 23, 2021
Last Verified:
Jul 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 23, 2021