ClinicalTrials.gov record NCT02798705

Physiologic Assessment of Microvascular Function in Patients With Cardiac Amyloidosis

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

Physiologic Assessment of Microvascular Function in Patients With Cardiac Amyloidosis: Prospective Registry and Pilot Study

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Age18 years old to 85 years old
SexAll
LocationSouth Korea
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This prospective registry and pilot study measures coronary microvascular function in people with cardiac amyloidosis. It uses invasive physiologic tests (CFR, IMR, FFR) and compares them with noninvasive tests and pathological measures. Participants are followed for outcomes including all-cause mortality over two years.

What it is studying. The study is testing how common and how severe coronary microvascular dysfunction is in cardiac amyloidosis by measuring invasive physiologic indices (coronary flow reserve [CFR], index of microcirculatory resistance [IMR], and fractional flow reserve [FFR]). It compares those invasive measurements with noninvasive tests (blood markers such as serum free light chain and NT-proBNP, Doppler echocardiography with 2D strain, and cardiac perfusion MRI) and with the percent of myocardial tissue involved by amyloid on pathology. The study also explores differences by disease severity and amyloidosis type and aims to find physiologic cut-offs that relate to later outcomes.

What the researchers hope to learn. To describe how often coronary microvascular dysfunction occurs in cardiac amyloidosis; to assess how invasive physiologic indices relate to noninvasive tests and to pathological amyloid burden; to explore differences by amyloid type and disease stage; and to identify physiologic cut-off values associated with mortality.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

Amyloidosis is rare systemic disorder characterized by the extracellular deposition of misfolded protein in various organ system, including heart. Among the several types of amyloid fibrils, the light chain and transthyretin amyloid proteins most commonly affect the heart. Cardiac amyloid deposits result in increased ventricular wall thickness and produce a restrictive cardiomyopathy presenting primarily as biventricular congestive heart failure. Anginal symptoms and signs of ischemia have been reported in some patients with cardiac amyloidosis without obstructive epicardial coronary artery disease (CAD). Autopsy studies have shown amyloid deposits around and between cardiac myocytes in the interstitium, the perivascular regions, and the media of intramyocardial coronary vessels. Amyloidosis is thus a prime example of a disorder with the potential to cause coronary microvascular dysfunction via 3 major mechanisms: (1) structural (amyloid deposition in the vessel wall causing wall thickening and luminal stenosis), (2) extravascular (extrinsic compression of the microvasculature from perivascular and interstitial amyloid deposits and decreased diastolic perfusion), and (3) functional (autonomic and endothelial dysfunction). Previous basic research presented that adipose arteriole or atrial coronary arterioles showed endothelial dysfunction even after brief exposure to physiologic amounts of light chain, and also showed increased oxidative stress, reduced NO bioavailability, and peroxynitrite production. All these previous evidences imply that coronary microvascular dysfunction and subsequent global ischemic insult can be precursor of overt diastolic or systolic dysfunction in patients with cardiac amyloidosis. However, there have only 1 study which evaluated microvascular function in vivo using N13-ammonium positron emission tomography (PET). In that study, Dorbala et al. demonstrated that amyloidosis patients showed depressed global resting myocardial blood flow (MBF), stress MBF, and CFR and higher minimal coronary vascular resistance, compared with patients with left ventricular hypertrophy. However, low availability, high cost, and limited resolution of N13 ammonium PET precludes the generalizability of the results. Since thermodilution-derived coronary flow reserve and index or microcirculatory reserve using pressure-temperature wire has been well validated prognostic index in assessment of patients with coronary artery disease or functionally insignificant epicardial coronary stenosis, invasive physiologic assessment might more specifically assess macro- and microvascular function in patients with cardiac amyloidosis. Moreover, adding physiologic measurement in the current frame in diagnosis of cardiac amyloidosis might enhance risk stratification of patients. Therefore, the current study will perform physiologic assessment including fractional flow reserve, coronary flow reserve, and index of microcirculatory resistance in patients with cardiac amyloidosis, and explore correlation among the physiologic indices and conventional measurements of echocardiography, perfusion MRI, serum light chain amount, or NT-proBNP. In addition, the differences of physiologic indices according to disease severity of cardiac amyloidosis, which measured by endomyocardial biopsy findings will be also explored. Since there was no previous study which performed invasive physiologic assessment in amyloidosis patients, this study will be performed as pilot study. Target sample size will be at least 30 patients.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will have invasive coronary angiography with physiologic measurements of the coronary circulation (fractional flow reserve, coronary flow reserve, and index of microcirculatory resistance). They may also have or provide results of heart imaging (echocardiography with strain and cardiac perfusion MRI) and blood tests for markers such as serum free light chain, troponin T, and NT‑proBNP. Available biopsy/pathology reports will be reviewed to compare tissue involvement with physiologic measures. The study includes follow-up for outcomes, including all-cause mortality, for up to two years.

How the study is structured. A prospective observational cohort (registry and pilot) where participants undergo invasive coronary physiologic measurements and noninvasive tests, with data collected and analyzed over about two years. No experimental treatment is assigned; the study observes measurements, compares tests, and follows clinical outcomes.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry lists this study under Cardiac Amyloidosis. Does it apply to my diagnosis?
  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in South Korea. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on wild-type ATTR amyloidosis

This trial is also listed on this site under ATTRv amyloidosis.

Important dates

Study start
Apr 11, 2016
Primary completion
April 2029 (estimated)
Study completion
December 2030 (estimated)
Target enrollment
30 participants (estimated)
Last updated on registry
Mar 14, 2025
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Samsung Medical Center
Principal investigator
Joo Myung Lee, Assistant professor
Samsung Medical Center

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

echocardiography
An ultrasound scan of the heart. A transesophageal echocardiogram is done through a probe passed into the food pipe for a closer view.
MRI
A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
biopsy
Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
positron emission tomography
A scan in which a small amount of a radioactive tracer is injected so that activity in tissues can be seen. Often combined with a CT or MRI scan.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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