RestoratIon of Myocardial Function by PeRcutaneous cOronary interVEntion in Patients With Ischemic CardioMyoPathy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorSeoul National University Hospital

About this trial

To compare the effects of physiology- and imaging-guided PCI combined with optimal medical therapy (OMT) versus OMT alone on the recovery of left ventricular systolic function in patients with ischemic cardiomyopathy and multivessel coronary artery disease.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subject must be ≥ 19 years

Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving invasive physiologic or imaging evaluation and PCI and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.

Subject with LV ejection fraction <40% from cardiac MRI

Subject with multivessel disease in major epicardial coronary artery disease or their major branches (vessel size of 2.5 mm or more than 2.5mm) considering coronary revascularization

Disqualifiers

Subjects with more than 50% transmural extent of infarction on GE-MRI in more than 25% of the dysfunctional myocardial segments

Subject with suspicious of other cardiomyopathy (dilated cardiomyopathy, hypertrophic cardiomyopathy etc.)

Subject with recent myocardial infarction within 4 weeks

Subject with recent fatal arrhythmia (VT or VF) within 4 weeks

Trial design

Design model

Parallel

Treatments tested in this trial

  • Physiology-and imaging-guided PCI

    Procedure/Surgery

    The criteria for performing revascularization are as follows 1. Lesions with ≥50% diameter stenosis and FFR ≤ 0.80, or lesions with severe stenosis (\>90%) 2. In vessels meeting the above criteria, IVUS findings consistent with either: * Minimum lumen area (MLA) ≤ 3 mm² * 3 mm² \< MLA ≤ 4 mm² and plaque burden \>70% For all target vessels and lesions identified for intervention, optimal revascularization should be pursued. The criteria for optimal revascularization are as follows, and operators are encouraged to achieve them: 1. Post-PCI FFR \> 0.86 in all treated vessels is recommended, with a minimum threshold of post-PCI FFR \> 0.80 to achieve functional complete revascularization. 2. Post-PCI ΔFFR (defined as \[FFR at stent distal edge\] - \[FFR at stent proximal edge\]) \< 0.05 is recommended. 3. On IVUS, achieving a minimum stent area (MSA) \> 5.5 mm² and MSA/average reference lumen \> 80% is recommended.

  • Optimal medical treatment

    Drug

    All study participants will receive guideline-directed medical therapy. Even for patients assigned to the optimal medical therapy group, revascularization may be performed during follow-up if clinically indicated. If such a decision is made prior to the primary endpoint assessment, a gadolinium-enhanced cardiac MRI will be performed at the time of consideration to reassess myocardial viability.

Treatment groups

158 Participants
are divided into 2 treatment groups
Group A: Physiology-and imaging-guided PCIExperimental treatment 1 intervention
Group B: Optimal medical treatmentActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

LV ejection fraction from GE-MRI

LV ejection fraction from gadolinium-enhanced MRI

Time frame
At 6 months after randomization

Secondary outcomes

1

Changes in the transmural extent of myocardial infarction from GE-MRI

Changes in the transmural extent of myocardial infarction from GE-MRI

Time frame
At 6 months after randomization
2

Number of improved dysfunctional myocardial segments from GE-MRI

Number of improved dysfunctional myocardial segments from GE-MRI

Time frame
At 6 months after randomization
3

Changes in the LV chamber size from GE MRI

Changes in the LV chamber size from GE MRI

Time frame
At 6 months after randomization
4

LV ejection fraction from echocardiography

LV ejection fraction from echocardiography

Time frame
At 6 months and 12 months after randomization

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Seoul National University Hospital

Lead sponsor

Seoul National University Bundang Hospital

Collaborator

Seoul National University Boramae Hospital

Collaborator