NCT02798731

Brief Summary

The aim of the study is to evaluate the impact of early microvascular disease assessed by coronary physiologic indices such as fractional flow reserve (FFR), coronary flow reserve (CFR), index of microvascular resistance (IMR) on future occurrence of cardiac allograft vasculopathy (CAV) in heart transplant recipients.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
56mo left

Started May 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%
May 2016Dec 2030

Study Start

First participant enrolled

May 1, 2016

Completed
1 month 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
14 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2030

Expected
6 months 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

14.1 years

First QC Date

June 9, 2016

Last Update Submit

March 12, 2025

Conditions

Cardiac Allograft Vasculopathy

Keywords

Heart transplantMicrovascular dysfunctionCardiac allograft vasculopathyFractional flow reserveCoronary flow reserveIndex of microvascular resistance

Outcome Measures

Primary Outcomes (2)

  • Rates of cardiac death between patients with or without overt microvascular disease (CFR≤2 and IMR≥25) diagnosed with physiologic evaluation at 2-year follow-up after heart transplantation

    72 months

  • Acute cellular rejection between patients with or without overt microvascular disease

    72 months

Secondary Outcomes (5)

  • Occurrence of anatomically significant cardiac allograft vasculopathy (% diameter stenosis > 50% on CCTA)

    72 months

  • Comparison of total aggregated plaque volume and presence of adverse plaque characteristics on CCTA between transplant patients with or without overt microvascular disease (CFR≤2 and IMR≥25).

    72 months

  • Comparison of all-cause mortality in transplant patients with or without overt microvascular disease (CFR≤2 and IMR≥25) diagnosed with physiologic evaluation at 2-year follow-up after heart transplantation.

    24 months

  • Comparison of rates of cardiac death in transplant patients with or without overt microvascular disease (CFR≤2 and IMR≥25) diagnosed with physiologic evaluation at 1-year follow-up after heart transplantation.

    72 months

  • Comparison of IVUS and physiologic indices in prediction of CAV progression.

    72 months

Eligibility Criteria

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

Consecutive patients who received heart transplant undergoing coronary angiography for evaluation of coronary disease

You may qualify if:

  • Subject over age of 18
  • Patients received heart transplant

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 (3)

  • Ha J, Lee SH, Choi KH, Shin D, Hong D, Kim D, Yang JH, Cho YH, Sung K, Park M, Kim JS, Park TK, Song YB, Hahn JY, Choi SH, Gwon HC, Oh JK, Choi JO, Lee JM. Microvascular Resistance Reserve and Prognosis After Heart Transplantation. JACC Cardiovasc Interv. 2025 Feb 24;18(4):439-452. doi: 10.1016/j.jcin.2024.11.011.

    PMID: 40010915DERIVED

  • Lee JM, Choi KH, Choi JO, Shin D, Park Y, Kim J, Lee SH, Kim D, Yang JH, Cho YH, Sung K, Choi JY, Park M, Kim JS, Park TK, Song YB, Hahn JY, Choi SH, Gwon HC, Oh JK, Jeon ES. Coronary Microcirculatory Dysfunction and Acute Cellular Rejection After Heart Transplantation. Circulation. 2021 Nov 2;144(18):1459-1472. doi: 10.1161/CIRCULATIONAHA.121.056158. Epub 2021 Sep 3.

    PMID: 34474597DERIVED

  • Lee SH, Choi KH, Lee JM, Hwang D, Rhee TM, Park J, Kim HK, Cho YK, Yoon HJ, Park J, Song YB, Hahn JY, Doh JH, Nam CW, Shin ES, Hur SH, Koo BK. Physiologic Characteristics and Clinical Outcomes of Patients With Discordance Between FFR and iFR. JACC Cardiovasc Interv. 2019 Oct 28;12(20):2018-2031. doi: 10.1016/j.jcin.2019.06.044. Epub 2019 Sep 25.

    PMID: 31563683DERIVED

Study Officials

  • Joo Myung Lee, MD, MPH

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

  • Jin-Oh Choi, MD, PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joo Myung Lee, MD, MPH

CONTACT

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 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

May 1, 2016

Primary Completion (Estimated)

June 1, 2030

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)