NCT02798705Recruiting
Physiologic Assessment of Microvascular Function in Patients With Cardiac Amyloidosis
Physiologic Assessment of Microvascular Function in Patients With Cardiac Amyloidosis: Prospective Registry and Pilot Study
Source: ClinicalTrials.gov · Last updated 14 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 30 (estimated)
- First submitted
- 9 Jun 2016
- Start date
- 11 Apr 2016
- Primary completion date
- 30 Apr 2029
- Lead sponsor
- Samsung Medical Center
- Diseases
- Amyloidosis
- NCT number
- NCT02798705
What you commit to
- Study type: Observational
- Planned participants: 30
- From 11 Apr 2016 to the primary completion date, 30 Apr 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with major bleeding in last 3 months
- Patients with active bleeding
- Patients with severe valvular heart disease
Other
- Patients with cardiogenic shock
- Patients with unstable vital sign that precludes coronary angiography
- Patients with coagulopathy
- Patients who refused to provide informed consent
Who the study is looking for
- 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
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.