Evaluating microvascular function in heart transplant patients
Physiologic Assessment of Microvascular Function and Its Impact on Cardiac Allograft Vasculopathy in Heart Transplant Patients: Prospective Registry and Pilot Study
This study is testing new ways to check blood flow in heart transplant patients to see if it can help spot early signs of heart problems that could lead to serious health issues.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Samsung Medical Center Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT02798731 on ClinicalTrials.gov |
What this trial studies
This study aims to assess early microvascular disease in heart transplant recipients by measuring coronary physiologic indices such as fractional flow reserve (FFR), coronary flow reserve (CFR), and index of microvascular resistance (IMR). The focus is on understanding how these indices relate to the future occurrence of cardiac allograft vasculopathy (CAV), a significant cause of morbidity and mortality in this population. By utilizing these advanced diagnostic techniques, the study seeks to improve early detection and management of CAV, which often presents without typical ischemic symptoms. The findings could lead to better screening protocols and interventions for heart transplant patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over the age of 18 who have received a heart transplant.
Not a fit: Patients experiencing cardiogenic shock, unstable vital signs, or those with severe valvular heart disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance early detection and management of cardiac allograft vasculopathy, potentially improving outcomes for heart transplant patients.
How similar studies have performed: Other studies have explored microvascular function in heart transplant patients, but this specific approach using FFR, CFR, and IMR is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subject over age of 18 * Patients received heart transplant Exclusion Criteria: * Patients with cardiogenic shock * Patients with unstable vital sign that precludes coronary angiography * Patients with major bleeding in last 3 months * Patients with active bleeding * Patients with coagulopathy * Patients with severe valvular heart disease * Patients who refused to provide informed consent
Where this trial is running
Seoul
- Samsung Medical Center — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Joo Myung Lee, MD, MPH — Samsung Medical Center
- Study coordinator: Joo Myung Lee, MD, MPH
- Email: drone80@hanmail.net
- Phone: 82-2-3410-1246
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.