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Cardiac AmyloidosisNCT02798705

Physiologic Assessment of Microvascular Function in Patients With Cardiac Amyloidosis

An observational study of Cardiac Amyloidosis, run by Samsung Medical Center at 1 site in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Cardiac Amyloidosis
How many people
30 participants
Where
1 siteSouth Korea
Study dates
11 Apr 2016to Dec 2030
How long will I take part?
2 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Pathologically confirmed amyloidosis patients with suspected cardiac involvement undergoing coronary angiography for coronary disease evaluation

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Joo Myung Lee, MD, MPH, PhD contact

82-2-3410-1246

drone80@hanmail.net

Ki Hong Choi, MD contact

82-2-3410-1246

cardiokh@gmail.com

South Korea1 site, 1 recruiting
  • Samsung Medical Center

    Seoul

    Joo Myung Lee, MD, MPH, 82-2-3410-1246, drone80@hanmail.net

    Recruiting

Other trials in South Korea

About this study

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

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.

Read the detailed description

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.

Keywords
Cardiac amyloidosis, Fractional flow reserve, Microvascular dysfunction, Coronary flow reserve, Index of microcirculatory resistance
Medical subject headings
Amyloid Neuropathies, Familial

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. all-cause mortality

    Comparison of all-cause mortality in amyloidosis patients with or without microvascular disease

    Measured: 2 Years

Secondary outcomes (8)
  1. Correlation between IMR and echocardiographic parameters

    Correlation between IMR and echocardiographic parameters (E/E', LV ejection fraction, etc.)

    Measured: within 3 months of diagnosis

  2. Correlation between IMR and serum biochemicalmarkers

    Correlation between IMR and serum biochemicalmarkers (troponin T, NT-proBNP, serum free light chain)

    Measured: within 3 months of diagnosis

  3. Distribution of CFR or IMR according to pathologic severity of myocardial involvement

    Distribution of CFR or IMR according to pathologic severity of myocardial involvement (Percent amyloid load)

    Measured: within 3 months of diagnosis

  4. Comparison of CFR or IMR value in amyloidosis patient with or without relative perfusion defect in myocardial perfusion imaging (ex> adenosine-SPECT or perfusion MRI)

    Measured: within 3 months of diagnosis

  5. Comparison of CFR or IMR value in different type of amyloidosis (AL type, hereditary type, AA type, senile type)

    Measured: within 3 months of diagnosis

  6. Comparison of CFR or IMR value in amyloidosis patient according to current staging by Troponin T, NT-proBNP and free light chain difference

    Measured: within 3 months of diagnosis

  7. Optimal cut-off values of physiologic indices (CFR, IMR) for prediction of all-cause mortality

    Measured: 2 Years

  8. Association between physiologic indices and pathologically measured percent area involvement in myocardial interstitium

    Measured: within 3 months of diagnosis

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2016 (estimated)
  2. Study start11 Apr 2016
  3. Primary completionApr 2029 (estimated)
  4. Study completionDec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
30 participants (estimated)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT02798705
Sponsor's protocol ID
AMYL2016-04-122
Status last verified
Mar 2025
First submitted
9 Jun 2016
Last updated
14 Mar 2025
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked

Publications

  • Choi KH, Lee JM, Kim SR, Kim D, Choi JO, Kim SJ, Kim K, Kim JS, Koo BK, Jeon ES. Prognostic Value of the Index of Microcirculatory Resistance Over Serum Biomarkers in Cardiac Amyloidosis. J Am Coll Cardiol. 2020 Feb 11;75(5):560-561. doi: 10.1016/j.jacc.2019.11.045. No abstract available.

    PubMed 32029139

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiac Amyloidosis, run by Samsung Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Joo Myung Lee, MD, MPH, PhD (82-2-3410-1246, drone80@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

all-cause mortality (time frame: 2 Years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02798705, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.

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