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Clinical Trials in South Korea / NCT02798705
Recruiting Observational

Physiologic Assessment of Microvascular Function in Patients With Cardiac Amyloidosis

NCT02798705 · tracked via the Priya Life Science South Korea tracker
Sponsor
Samsung Medical Center
Phase
Observational
Started
2016-04-11
Last updated
2025-03-14

Condition(s) studied

Cardiac Amyloidosis

Study summary

The aim of the study is to evaluate coronary flow reserve (CFR), index of microcirculatory resistance (IMR), and proportion of overt microvascular disease, defined as depressed CFR as well as elevated IMR in patients with cardiac amyloidosis. The second objective of this study is to compare results of non-invasive test including serum light chain amount, Doppler echocardiography with 2D strain, and cardiac perfusion MRI. The third object of this study is to evaluate the association between physiologic indices and pathologically measured percent area involvement of interstitium.

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • all-cause mortality — 2 Years
    Comparison of all-cause mortality in amyloidosis patients with or without microvascular disease

Trial sites (1)

FacilityCityRegionStatus
Samsung Medical Center Seoul South Korea Recruiting

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Other trials for the same condition

Early Detection of Concealed Cardiac Amyloidosis Using AI-ECG and CT-Derived Extracellular Volume in Patients With Atrial Fibrillation Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02798705 on ClinicalTrials.gov ↗ ← All trials in South Korea