Clinical trial NCT03776682: Myocardial Inflammation in Rheumatoid Arthritis: A Descriptive Study
Official title: Myocardial Inflammation in Rheumatoid Arthritis: A Descriptive Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Inflammation
Rheumatoid Arthritis
Coronary Artery Disease
Myocardial Strain
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-12-17
Enrollment: 35
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Subclinical myocardial inflammatory burden as detected by PET imaging
timeFrame: 14 days
measure: Relationship of presence of myocardial inflammation to atherosclerotic burden
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Rekha Mankad, MD
role: PRINCIPAL_INVESTIGATOR
References: