Examining heart changes in patients undergoing rehabilitation or bariatric surgery
Cardiovascular Imaging to Assess Responses to Metabolic Interventions
This study is testing how heart changes in people improve after they go through rehabilitation or weight-loss surgery to see if these changes can help spot heart problems early.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT05650307 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate how cardiac microstructure changes in patients before and after undergoing cardiac rehabilitation or bariatric surgery. Using cardiac MRI, the study will assess the relationship between these microstructural changes and overall cardiac function and structure. The research will involve a longitudinal cohort design, with participants undergoing MRI scans at the beginning and end of a 12-week rehabilitation program. The goal is to identify early indicators of cardiovascular disease through these imaging techniques.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years with symptomatic cardiovascular disease or those eligible for bariatric surgery.
Not a fit: Patients with contraindications to MRI or those from vulnerable populations, such as prisoners, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection and management of cardiovascular diseases in patients undergoing metabolic interventions.
How similar studies have performed: Other studies have shown promising results in using cardiac MRI to assess heart conditions, suggesting that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \> 18 years of age * Provision of written informed consent * For bariatric surgery group, obesity (BMI\>/=30 kg/m2) and non-obese (BMI \<30 kg/m2; for control group) * For cardiac rehabilitation group, symptomatic cardiovascular disease for patients and no signs of cardiovascular disease for healthy controls Exclusion Criteria: * Vulnerable populations will be excluded from this study including Prisoners * Contraindication to CMR imaging to be determined by standard MRI protocols * Decisionally impaired (e.g. dementia or cognitive disability)
Where this trial is running
Cleveland, Ohio
- Cardiovascular Innovation Research Center — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: CIRC Program Coordinator
- Email: circ@ccf.org
- Phone: 216 636-5373
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.