NCT02798705

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
55mo left

Started Apr 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Apr 2016Dec 2030

Study Start

First participant enrolled

April 11, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 14, 2016

Completed
12.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2029

Expected
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

March 14, 2025

Status Verified

March 1, 2025

Enrollment Period

13 years

First QC Date

June 9, 2016

Last Update Submit

March 12, 2025

Conditions

Cardiac Amyloidosis

Keywords

Cardiac amyloidosisFractional flow reserveMicrovascular dysfunctionCoronary flow reserveIndex of microcirculatory resistance

Outcome Measures

Primary Outcomes (1)

  • all-cause mortality

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

    2 Years

Secondary Outcomes (8)

  • Correlation between IMR and echocardiographic parameters

    within 3 months of diagnosis

  • Correlation between IMR and serum biochemicalmarkers

    within 3 months of diagnosis

  • Distribution of CFR or IMR according to pathologic severity of myocardial involvement

    within 3 months of diagnosis

  • 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)

    within 3 months of diagnosis

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

    within 3 months of diagnosis

  • +3 more secondary outcomes

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

RECRUITING

Related Publications (1)

  • 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.

    PMID: 32029139DERIVED

MeSH Terms

Conditions

Amyloid Neuropathies, Familial

Condition Hierarchy (Ancestors)

Heredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesNervous System DiseasesAmyloid NeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesAmyloidosis, FamilialMetabolism, Inborn ErrorsMetabolic DiseasesNutritional and Metabolic DiseasesAmyloidosisProteostasis Deficiencies

Study Officials

  • Joo Myung Lee, MD, MPH, PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

  • Eun-Seok Jeon, MD, PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joo Myung Lee, MD, MPH, PhD

CONTACT

82-2-3410-1246drone80@hanmail.net

Ki Hong Choi, MD

CONTACT

82-2-3410-1246cardiokh@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

June 9, 2016

First Posted

June 14, 2016

Study Start

April 11, 2016

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

December 1, 2030

Last Updated

March 14, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked

Locations

KR(1)