NCT02798705 Physiologic Assessment of Microvascular Function in Patients With Cardiac Amyloidosis
| NCT ID | NCT02798705 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Samsung Medical Center |
| Condition | Cardiac Amyloidosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2016-04-11 |
| Primary Completion | 2029-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2016-04-11 with a primary completion date of 2029-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Joo Myung Lee, MD, MPH, PhD
PRINCIPAL INVESTIGATOR
Samsung Medical Center
Frequently Asked Questions
Who can join the NCT02798705 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Cardiac Amyloidosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02798705 currently recruiting?
Yes, NCT02798705 is actively recruiting participants. Contact the research team at drone80@hanmail.net for enrollment information.
Where is the NCT02798705 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT02798705 clinical trial?
NCT02798705 is sponsored by Samsung Medical Center. The principal investigator is Joo Myung Lee, MD, MPH, PhD at Samsung Medical Center. The trial plans to enroll 30 participants.