Assessing microvascular function in patients with cardiac amyloidosis
Official title: Physiologic Assessment of Microvascular Function in Patients With Cardiac Amyloidosis: Prospective Registry and Pilot Study
Run by Samsung Medical Center · NCT02798705 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years to 85 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Samsung Medical Center Academic / other |
| Locations | 1 site (Seoul) |
| Status | Recruiting |
| Started | April 11, 2016 |
| Main results expected | April 2029 |
| Study ends | December 2030 |
| Registry record updated | March 14, 2025 |
| Trial ID | NCT02798705 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18-85 with confirmed cardiac amyloidosis through heart biopsy or other biopsies showing cardiac involvement.
✕Probably not a fit
Patients experiencing cardiogenic shock or those with unstable vital signs may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Previous studies have indicated potential for success in understanding microvascular dysfunction in similar conditions, but this specific approach remains novel.
Who can join: the full rules
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 it's running
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Liver and Coagulation Markers in ATTR Cardiac Amyloidosis
This study tests liver function and blood-clotting markers in people with ATTR-CA to see if they reflect disease severity and progression.
-
Cardiac Amyloidosis: See if Intracardiac Thrombi are Common on CT
This study tests whether a contrast-enhanced cardiac CT can reliably detect intracardiac thrombi in adults with cardiac amyloidosis.
-
Higher pacemaker rate for people with cardiac amyloidosis
This study will see if temporarily increasing the pacemaker rate improves heart-failure symptoms and exercise tolerance in adults with cardiac amyloidosis who already have pacemakers.
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Using [64Cu]FBP8 PET/MR to find intracardiac blood clots in cardiac amyloidosis
We'll test whether a [64Cu]FBP8 PET/MR scan can find blood clots inside the heart of people with cardiac amyloidosis who have atrial fibrillation or atrial flutter.
-
Chest pain screening for hidden cardiac amyloidosis
We will test whether men over 65 who have chest pain but no coronary artery disease might have hidden cardiac amyloidosis using blood and urine tests, ECG and echocardiography, bone scintigraphy, and sometimes a heart biopsy.
-
Using advanced heart MRI to improve diagnosis and risk prediction for rare cardiomyopathies
This project tests whether advanced cardiac MRI techniques can help diagnose and predict future risk for people with rare heart muscle diseases like Danon, Fabry, cardiac amyloidosis, Noonan syndrome, and cardiac sarcoidosis.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.