NCT05828719

Brief Summary

Randomized trial to compare clinical outcomes between revascularization versus medical treatment alone in patients with ischemic cardiomyopathy and left ventricular dysfunction.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
900

participants targeted

Target at P75+ for not_applicable

Timeline
57mo left

Started Jun 2023

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Progress38%
Jun 2023Dec 2030

First Submitted

Initial submission to the registry

April 12, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 25, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

June 16, 2023

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

Expected
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

March 14, 2025

Status Verified

March 1, 2025

Enrollment Period

5 years

First QC Date

April 12, 2023

Last Update Submit

March 12, 2025

Conditions

Heart Failure With Reduced Ejection FractionIschemic Cardiomyopathy

Keywords

ischemic cardiomyopathypercutaneous coronary interventionejection fractionguideline-directed medical treatment

Outcome Measures

Primary Outcomes (1)

  • major adverse cardiac events [MACE]

    a composite of death, myocardial infarction (MI), admission for heart failure, or advanced heart failure requiring LVAD or transplantation

    2 years after last patient enrollment

Secondary Outcomes (14)

  • All-cause death

    2 years after last patient enrollment

  • Cardiac death

    2 years after last patient enrollment

  • Any myocardial infarction

    2 years after last patient enrollment

  • Spontaneous myocardial infarction

    2 years after last patient enrollment

  • Procedure-related myocardial infarction

    After index procedure

  • +9 more secondary outcomes

Study Arms (2)

Guideline-directed medical treatment group

NO INTERVENTION

In the GDMT group, medical treatment for patients with left ventricular dysfunction will be performed under current ACC/AHA/SCAI or ESC/EACTS guidelines for heart failure.

Revascularization group

EXPERIMENTAL

In the revascularization group, patients will undergo percutaneous coronary intervention (PCI) using standard techniques under current ACC/AHA/SCAI or ESC/EACTS guidelines. In the revascularization group, the procedure must be within 2 weeks of randomization. Revascularization criteria is presented as below. Revascularization indication 1. Diameter stenosis \>90% by visual assessment 2. Functionally significant stenosis (FFR≤0.80 or non-hyperemic pressure ratios≤0.89) 3. Chronic total occlusion with substantial ischemic territory. The below locations will be judged as having substantial ischemic territory. * Left main artery * Proximal to mid left anterior descending artery * Proximal left circumflex artery in left dominant coronary arterial system * Proximal to distal right coronary artery in right dominant coronary arterial system

Procedure: Percutaneous coronary intervention

Interventions

Percutaneous coronary interventionPROCEDURE

Revascularization indication 1. Diameter stenosis \>90% by visual assessment 2. Functionally significant stenosis (FFR≤0.80 or non-hyperemic pressure ratios≤0.89) 3. Chronic total occlusion with substantial ischemic territory. The below locations will be judged as having substantial ischemic territory. * Left main artery * Proximal to mid left anterior descending artery * Proximal left circumflex artery in left dominant coronary arterial system * Proximal to distal right coronary artery in right dominant coronary arterial system

Revascularization group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject must be at least 19 years of age
  • Patients with stage C heart failure and left ventricular ejection fraction\<40%
  • Patients with significant coronary artery stenosis (diameter stenosis\>50% with proven inducible myocardial ischemia by invasive physiologic assessment)
  • Coronary artery disease is amenable for percutaneous coronary intervention (PCI)
  • Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving invasive approach and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.

You may not qualify if:

  • Myocardial infarction by universal definition within 4 weeks of randomization
  • Non-viable myocardium in myocardial viability test (cardiac magnetic resonance, dobutamine-stress echocardiography, delayed single-photon emission computerized tomography, or aneurysmal change in echocardiography)
  • Target lesions not amenable for PCI by operators' decision
  • Patients who need left ventricular assisted device (LVAD) or heart transplantation at the time of randomization
  • Intolerance to Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Heparin, or Everolimus
  • Known true anaphylaxis to contrast medium (not allergic reaction but anaphylactic shock)
  • Pregnancy or breast feeding
  • Non-cardiac co-morbid conditions are present with life expectancy \<2 year or that may result in protocol non-compliance (per site investigator's medical judgment)
  • Unwillingness or inability to comply with the procedures described in this protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsune Medical Center

Seoul, 06351, South Korea

RECRUITING

MeSH Terms

Interventions

Percutaneous Coronary Intervention

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Young Bin Song, MD, PhD

    Samsung Medical Center

    STUDY CHAIR

  • Young Bin Song, MD, PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

  • Joo Myung Lee, MD, MPH, PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Young Bin Song, MD, PhD

CONTACT

82-2-3410-6653youngbien.song@samsung.com

Joo Myung Lee, MD, MPH, PhD

CONTACT

82-2-3410-3419drone80@hanmail.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Clinical outcome assessment will be performed under blinded assessment about the allocated treatment group.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective, multi-center, open-label, randomized controlled, superiority trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 12, 2023

First Posted

April 25, 2023

Study Start

June 16, 2023

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

December 31, 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

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked
Access Criteria
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)