An observational study in Myocardial Inflammation, Rheumatoid Arthritis and Coronary Artery Disease, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2023-07-10.
Sponsored by Mayo Clinic · Observational
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.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 35 is below the median of 155 across 1,057 observational studies indexed under Arthritis.
Browse Arthritis studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 669 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
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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.
Exclusion Criteria
Patients with RA and active inflammation (by exam or inflammatory markers)
Patients with RA who are in remission (clinically)
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.
Time frame: 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.
Time frame: 7 days
Plan to share: No
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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