Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03776682
Other study ID # 17-009867
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 22, 2018
Est. completion date May 26, 2023

Study information

Verified date July 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date May 26, 2023
Est. primary completion date May 26, 2023
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility 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 Design


Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
See also
  Status Clinical Trial Phase
Recruiting NCT06030596 - SPECT Myocardial Blood Flow Quantification for Diagnosis of Ischemic Heart Disease Determined by Fraction Flow Reserve
Completed NCT04080700 - Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach (KODRA)
Recruiting NCT03810599 - Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study N/A
Recruiting NCT06002932 - Comparison of PROVISIONal 1-stent Strategy With DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions. N/A
Not yet recruiting NCT06032572 - Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE) N/A
Recruiting NCT04242134 - Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions N/A
Recruiting NCT05308719 - Nasal Oxygen Therapy After Cardiac Surgery N/A
Completed NCT04556994 - Phase 1 Cardiac Rehabilitation With and Without Lower Limb Paddling Effects in Post CABG Patients. N/A
Recruiting NCT05846893 - Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease N/A
Recruiting NCT06027788 - CTSN Embolic Protection Trial N/A
Recruiting NCT05023629 - STunning After Balloon Occlusion N/A
Completed NCT04941560 - Assessing the Association Between Multi-dimension Facial Characteristics and Coronary Artery Diseases
Completed NCT04006288 - Switching From DAPT to Dual Pathway Inhibition With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease Phase 4
Completed NCT01860274 - Meshed Vein Graft Patency Trial - VEST N/A
Recruiting NCT06174090 - The Effect of Video Education on Pain, Anxiety and Knowledge Levels of Coronary Bypass Graft Surgery Patients N/A
Completed NCT03968809 - Role of Cardioflux in Predicting Coronary Artery Disease (CAD) Outcomes
Terminated NCT03959072 - Cardiac Cath Lab Staff Radiation Exposure
Recruiting NCT04566497 - Assessment of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up. N/A
Recruiting NCT05065073 - Iso-Osmolar vs. Low-Osmolar Contrast Agents for Optical Coherence Tomography Phase 4
Completed NCT05096442 - Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in Korean Patients With Coronary De Novo Lesions N/A

External Links