search
Back to results

Revascularization Versus Medical Treatment in Patients With Ischemic Left Ventricular Dysfunction (RESTORE-PCI)

Primary Purpose

Heart Failure With Reduced Ejection Fraction, Ischemic Cardiomyopathy

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Percutaneous coronary intervention
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure With Reduced Ejection Fraction focused on measuring ischemic cardiomyopathy, percutaneous coronary intervention, ejection fraction, guideline-directed medical treatment

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Samsune Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Guideline-directed medical treatment group

Revascularization group

Arm Description

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.

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 Diameter stenosis >90% by visual assessment Functionally significant stenosis (FFR≤0.80 or non-hyperemic pressure ratios≤0.89) 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

Outcomes

Primary Outcome Measures

major adverse cardiac events [MACE]
a composite of death, myocardial infarction (MI), admission for heart failure, or advanced heart failure requiring LVAD or transplantation

Secondary Outcome Measures

All-cause death
All-cause death
Cardiac death
Cardiac death
Any myocardial infarction
Any myocardial infarction by Forth Universal definition of MI
Spontaneous myocardial infarction
Spontaneous myocardial infarction by Forth Universal definition of MI
Procedure-related myocardial infarction
Procedure-related myocardial infarction by ARC II definition
Admission for heart failure
Admission for acute decompensated heart failure
Advanced heart failure requiring LVAD or transplantation
Advanced heart failure requiring LVAD or transplantation
Implantable cardioverter-defibrillator (ICD) or Cardiac resynchronization therapy (CRT-D)
Incidence of Implantable cardioverter-defibrillator (ICD) or Cardiac resynchronization therapy (CRT-D) for documented ventricular tachycardia or ventricular fibrillation (secondary prevention).
Clinically-indicated unplanned revascularization
Clinically-indicated unplanned revascularization
Stroke
Stroke (ischemic or hemorrhagic)
EQ-5D-5L (quality of life)
EQ-5D-5L (quality of life)
SAQ (angina severity)
SAQ (angina severity)
Left ventricular ejection fraction
Left ventricular ejection fraction by echocardiography
NT-proBNP
NT-proBNP, pg/mL

Full Information

First Posted
April 12, 2023
Last Updated
July 13, 2023
Sponsor
Samsung Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT05828719
Brief Title
Revascularization Versus Medical Treatment in Patients With Ischemic Left Ventricular Dysfunction
Acronym
RESTORE-PCI
Official Title
Randomized Controlled Trial of Revascularization Versus Medical Treatment on Clinical Outcomes in Patients With Reduced Left Ventricular Function
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 16, 2023 (Actual)
Primary Completion Date
July 1, 2028 (Anticipated)
Study Completion Date
December 31, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Randomized trial to compare clinical outcomes between revascularization versus medical treatment alone in patients with ischemic cardiomyopathy and left ventricular dysfunction.
Detailed Description
Ischemic cardiomyopathy, the term used to describe systolic dysfunction due to chronic myocardial ischemia from ischemic heart disease, is the most common form of heart failure. To adapt to this ischemic environment, myocardium is known to undergo downregulation that may revert after adequate perfusion is re-established, a phenomenon known as myocardium hibernation. This phenomenon has been a background for the main concept of management for ischemic cardiomyopathy via revascularization. Indeed, the recent 10-year follow-up reports from STICH trial demonstrated improved long-term clinical outcomes after coronary bypass graft surgery than optimal medical therapy (OMT) in patients with ischemic cardiomyopathy. Percutaneous coronary intervention (PCI) is another intervention that is commonly used to revascularize significant coronary stenosis. Despite common belief that revascularization by PCI would improve perfusion to ischemic myocardium and improve clinical outcomes, several clinical trials have failed to show beneficial impact of PCI over OMT in stable ischemic heart disease other than symptomatic improvement. Recently published REVIVED trial compared effect of PCI and OMT in ischemic cardiomyopathy patients with left ventricular ejection fraction < 35% and demonstrable viable myocardial segments, and found no significant difference in clinical outcomes of both groups. However, whether PCI optimized by additional information can make a difference in this setting remains unanswered. It is known that intravascular imaging and coronary physiologic testing using intravascular ultrasound (IVUS), optical coherence tomography (OCT) or fractional flow reserve (FFR) result in better outcomes compared to conventional angiography alone. IVUS provides anatomical information regarding the lumen, plaque, and plaque characteristics, and can optimize stent placement minimizing stent-related problems and lead to better outcomes. On the other hand, FFR provides information on amount of ischemia which the stenosis in question is causing, and also improves the quality of PCI which has been demonstrated by multiple previous trials. Unfortunately, proportion of IVUS and FFR use is not disclosed in REVIVED trial, and it is possible there is a room for improvement if the PCI is further guided by these adjunctive diagnostic procedures in regard to the clinical outcomes. In this regard, it is our hypothesis that PCI guided and optimized by intravascular imaging and FFR-guided strategy would bring additional benefit that may result in significant difference of prognosis for ischemic cardiomyopathy compared to OMT alone. Randomized controlled trial to test this hypothesis would provide valuable evidence to guide treatment strategy for ischemic cardiomyopathy. Therefore, RESTORE-PCI trial has been designed to compare clinical outcomes after state-of-the-art PCI or OMT for ischemic cardiomyopathy. The aim of the study is to compare clinical outcomes between revascularization versus medical treatment alone in patients with ischemic cardiomyopathy and left ventricular dysfunction. Primary hypothesis is that revascularization guided by invasive physiologic indexes and optimized by intravascular imaging device plus optimal medical treatment (OMT) would reduce risk of primary composite end point (major adverse cardiac events [MACE], a composite of death, myocardial infarction (MI), admission for heart failure, or advanced heart failure requiring LVAD or transplantation) than OMT alone in patients with ischemic cardiomyopathy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure With Reduced Ejection Fraction, Ischemic Cardiomyopathy
Keywords
ischemic cardiomyopathy, percutaneous coronary intervention, ejection fraction, guideline-directed medical treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, multi-center, open-label, randomized controlled, superiority trial
Masking
Outcomes Assessor
Masking Description
Clinical outcome assessment will be performed under blinded assessment about the allocated treatment group.
Allocation
Randomized
Enrollment
900 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Guideline-directed medical treatment group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Revascularization group
Arm Type
Experimental
Arm Description
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 Diameter stenosis >90% by visual assessment Functionally significant stenosis (FFR≤0.80 or non-hyperemic pressure ratios≤0.89) 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
Intervention Type
Procedure
Intervention Name(s)
Percutaneous coronary intervention
Intervention Description
Revascularization indication Diameter stenosis >90% by visual assessment Functionally significant stenosis (FFR≤0.80 or non-hyperemic pressure ratios≤0.89) 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
Primary Outcome Measure Information:
Title
major adverse cardiac events [MACE]
Description
a composite of death, myocardial infarction (MI), admission for heart failure, or advanced heart failure requiring LVAD or transplantation
Time Frame
2 years after last patient enrollment
Secondary Outcome Measure Information:
Title
All-cause death
Description
All-cause death
Time Frame
2 years after last patient enrollment
Title
Cardiac death
Description
Cardiac death
Time Frame
2 years after last patient enrollment
Title
Any myocardial infarction
Description
Any myocardial infarction by Forth Universal definition of MI
Time Frame
2 years after last patient enrollment
Title
Spontaneous myocardial infarction
Description
Spontaneous myocardial infarction by Forth Universal definition of MI
Time Frame
2 years after last patient enrollment
Title
Procedure-related myocardial infarction
Description
Procedure-related myocardial infarction by ARC II definition
Time Frame
After index procedure
Title
Admission for heart failure
Description
Admission for acute decompensated heart failure
Time Frame
2 years after last patient enrollment
Title
Advanced heart failure requiring LVAD or transplantation
Description
Advanced heart failure requiring LVAD or transplantation
Time Frame
2 years after last patient enrollment
Title
Implantable cardioverter-defibrillator (ICD) or Cardiac resynchronization therapy (CRT-D)
Description
Incidence of Implantable cardioverter-defibrillator (ICD) or Cardiac resynchronization therapy (CRT-D) for documented ventricular tachycardia or ventricular fibrillation (secondary prevention).
Time Frame
2 years after last patient enrollment
Title
Clinically-indicated unplanned revascularization
Description
Clinically-indicated unplanned revascularization
Time Frame
2 years after last patient enrollment
Title
Stroke
Description
Stroke (ischemic or hemorrhagic)
Time Frame
2 years after last patient enrollment
Title
EQ-5D-5L (quality of life)
Description
EQ-5D-5L (quality of life)
Time Frame
at 6 month after index procedure
Title
SAQ (angina severity)
Description
SAQ (angina severity)
Time Frame
at 6 month after index procedure
Title
Left ventricular ejection fraction
Description
Left ventricular ejection fraction by echocardiography
Time Frame
at 6 month - 1 year follow-up after index procedure
Title
NT-proBNP
Description
NT-proBNP, pg/mL
Time Frame
at 6 month - 1 year follow-up after index procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Young Bin Song, MD, PhD
Phone
82-2-3410-6653
Email
youngbien.song@samsung.com
First Name & Middle Initial & Last Name or Official Title & Degree
Joo Myung Lee, MD, MPH, PhD
Phone
82-2-3410-3419
Email
drone80@hanmail.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young Bin Song, MD, PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Young Bin Song, MD, PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joo Myung Lee, MD, MPH, PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsune Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young Bin Song, MD, PhD
Phone
0234102575
Email
youngbin.song@gmail.com
First Name & Middle Initial & Last Name & Degree
Joo Myung Lee, MD, MPH, PhD
Phone
0234102575
Email
drone80@hanmail.net

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked
IPD Sharing Time Frame
After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked
IPD Sharing Access Criteria
After publication of first manuscript and trial results, the de-identified data will be shared by permission of principle investigator, when asked

Learn more about this trial

Revascularization Versus Medical Treatment in Patients With Ischemic Left Ventricular Dysfunction

We'll reach out to this number within 24 hrs