CV Imaging of Metabolic Interventions

CV Imaging of Metabolic Interventions

The primary clinical objective of the clinical study is to (1) determine cardiac microstructural phenotypes by cardiac MRI in patients before and after cardiac rehabilitation, or bariatric surgery, and their relationship to cardiac structure/function.
Aim 1: How does the heart’s microstructure change before and after cardiac rehabilitation or bariatric surgery? Is this linked to other prevalent macro structure and functional abnormalities and how they change after each metabolic intervention (e.g., cardiac mass or strain)?
Our hypothesis is that characteristic alterations in myocardial microstructure reflected in non-contrast MRI are prevalent in symptomatic cardiovascular disease before and after the respective interventions and may help early detection of cardiovascular disease.
The investigators have chosen a prospective longitudinal cohort design to test the hypothesis that cardiac structure and function change significantly following cardiac rehabilitation or bariatric surgery.
There are TWO arms of the study:
The study protocol for those undergoing cardiac rehabilitation will involve:

Consent
MRI at the beginning of 12 weeks of cardiac rehabilitation at Cleveland Clinic. Subjects may opt to complete an MRI of the leg in addition to the cardiac MRI. Patients who opt for both have the option to complete the scans at separate visits.
Subjects will be scheduled for a 6 week scan if available; however, participation will be optional
MRI after 12 weeks of cardiac rehabilitation at the Cardiovascular Disease Prevention Center at Cleveland Clinic. If subjects opted to complete both a cardiac scan and a leg scan, the patients have the option to complete these at separate visits.

The study protocol for those who participate in bariatric surgery study:

Consent
MRI prior to the bariatric surgery.
MRI within 12 months of surgery.

Optionally, if the subjects agree, the blood samples will be collected:
• Give blood sample for research purpose only. The blood draw is used to correlate the clinical blood biomarkers to the cardiac MRI data to help us better understand and validate the clinical utility of the novel cardiac MRI techniques. The blood draws should approximately take 20 minutes. The blood draw will take place in the doctor’s office or at Mellen center private preparation by a registered nurse or approved technician. The blood will be stored at Lerner freezers until needed for analysis and being analyzed for biomarkers only for this study. It will not be used for future research in the Cleveland Clinic. Only members of the research team will have access to the samples.
The study protocol for healthy volunteers will involve:

Consent
One MRI Scan

Source: View full study details on ClinicalTrials.gov

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December 15, 2022Comments OffCardiology | Cardiology Clinical Trials | Cardiology Studies | ClinicalTrials.gov | Drug Trials Near Me | US National Library of Medicine
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