Ignite Creation Date:
2024-05-06 @ 6:24 PM
Last Modification Date:
2024-10-26 @ 2:47 PM
Study NCT ID:
NCT05650307
Status:
RECRUITING
Last Update Posted:
2024-02-07
First Post:
2022-11-27
Brief Title:
CV Imaging of Metabolic Interventions
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
Cardiovascular Imaging to Assess Responses to Metabolic Interventions
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CIRCMeta
Brief Summary:
Cardiovascular disease is the leading cause of death worldwide It is becoming clearer that heart failure HF is closely associated with bodys metabolism Even before the heart becomes weaker it responds to the stresses by changing the fuels it burns which results in a reduction in the hearts metabolic efficiency that worsens the hearts condition Since the heart burns so much fuel and consumes fats and carbohydrates along with other available substrates any changes in its metabolic efficiency could impact metabolism throughout the body Specifically HF is characterized by limited flexibility in substrate utilization leading to an overall energetic deficit Such energetic deficit is associated with progressive remodeling and alter cardiac hemodynamics For example obesity is a widely known risk factor for cardiovascular disease likely lie in how the heart handles energy substrate utilization and energetics One commonly recommended treatment for cardiovascular disease especially coronary artery disease CAD or congestive heart failure CHF is cardiac rehabilitation Cardiac rehabilitation for symptomatic cardiovascular disease has been shown to promote a healthy lifestyle improve physical health and reduce cardiovascular death iii with an apparent dose-dependent response Participation results in a reduced risk of hospitalization and revascularization procedures and improved functional status in randomized controlled trials Thus cardiac rehabilitation is recommended for individuals with symptomatic CAD or CHF by the American College of Cardiology and American Heart Association In addition exercise training in preclinical animal models mirroring the exercise component of cardiac rehabilitation routines have shown increased myocardial regeneration and cardioprotective molecular effects ameliorating adverse myocardial remodeling Despite these benefits there is vast heterogeneity in the efficiency of cardiac rehabilitation on the individual level with large variances in improved exercise capacity and cardiac function recovery Personalization of cardiac rehabilitation necessitates a non-invasive approach to monitor the direct beneficial effects on the heart and more ideally predict efficacy at baseline Taken together understanding how metabolic interventions including bariatric surgery and cardiac rehabilitation change myocardial structure and function is critical for the prevention diagnosis and prognosis for patients with cardiovascular diseases
Advanced cardiovascular imaging using Magnetic Resonance Imaging MRI has proven to be effective in providing gold standard myocardial tissue characterization Our team has developed novel cardiac MRI techniques that leverages endogenous tissue properties to reveal a milieu of deep tissue phenotypes including myocardial inflammation fibrosis metabolism and microstructural defects Among these phenotypes myocardial microstructure has proven to be most sensitive to early myocardial tissue damage and is predictive of myocardial regeneration In collaboration with cardiologists at Cleveland Clinic the investigators aim to study how myocardial microstructure revealed by cardiac MRI changes cardiovascular disease patient population before and after metabolic interventions
Advanced cardiovascular imaging using Magnetic Resonance Imaging MRI has proven to be effective in providing gold standard myocardial tissue characterization Our team has developed novel cardiac MRI techniques that leverages endogenous tissue properties to reveal a milieu of deep tissue phenotypes including myocardial inflammation fibrosis metabolism and microstructural defects Among these phenotypes myocardial microstructure has proven to be most sensitive to early myocardial tissue damage and is predictive of myocardial regeneration In collaboration with cardiologists at Cleveland Clinic the investigators aim to study how myocardial microstructure revealed by cardiac MRI changes cardiovascular disease patient population before and after metabolic interventions
Detailed Description:
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 structurefunction
Aim 1 How does the hearts 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 eg 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 doctors 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
Aim 1 How does the hearts 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 eg 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 doctors 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None