Assessing microvascular function in patients with cardiac amyloidosis
Physiologic Assessment of Microvascular Function in Patients With Cardiac Amyloidosis: Prospective Registry and Pilot Study
This study is testing how well the tiny blood vessels in the hearts of people with cardiac amyloidosis are working to see if it can help understand their condition better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Samsung Medical Center Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT02798705 on ClinicalTrials.gov |
What this trial studies
This study evaluates coronary flow reserve (CFR) and the index of microcirculatory resistance (IMR) in patients diagnosed with cardiac amyloidosis. It aims to identify the prevalence of microvascular disease by measuring depressed CFR and elevated IMR, while also comparing non-invasive tests such as serum light chain levels and cardiac perfusion MRI. Additionally, the study seeks to correlate physiological indices with the pathological extent of interstitial involvement in the heart. The findings could enhance understanding of microvascular dysfunction in this patient population.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-85 with confirmed cardiac amyloidosis through heart biopsy or other biopsies showing cardiac involvement.
Not a fit: Patients experiencing cardiogenic shock or those with unstable vital signs may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic and therapeutic strategies for patients with cardiac amyloidosis.
How similar studies have performed: Previous studies have indicated potential for success in understanding microvascular dysfunction in similar conditions, but this specific approach remains novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subject age 18-85 years old * Patients with confirmed cardiac amyloidosis by heart biopsy * Patients with confirmed amyloidosis by biopsy other than heart and evidence of cardiac involvement in echocardiography * Patients who underwent invasive physiologic assessment within 3 months from diagnosis of primary disease 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, PhD — Samsung Medical Center
- Study coordinator: Joo Myung Lee, MD, MPH, PhD
- 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.