Clinical trial Recruiting at 1 site Observational Ages 18 to 85

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 typeObservational
Ages18 Years to 85 Years
SexAll
Enrollment30 (estimated)
SponsorSamsung Medical Center
Academic / other
Locations1 site (Seoul)
StatusRecruiting
StartedApril 11, 2016
Main results expectedApril 2029
Study endsDecember 2030
Registry record updatedMarch 14, 2025
Trial IDNCT02798705 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

  • 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.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.