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Diabetes-Centered Evaluation of Revascularization Strategy of Functional and Imaging-CombiNEd State-of-the-Art Percutaneous Coronary Intervention or Coronary-Artery Bypass Grafting in Patients With Diabetes Mellitus and Multivessel Coronary Artery Disease (DEFINE-DM)

Primary Purpose

Coronary Artery Stenosis

Status
Not yet recruiting
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
State-of-the-Art Percutaneous Coronary Intervention
standard CABG
Sponsored by
Duk-Woo Park, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Stenosis focused on measuring Multivessel Coronary Artery Disease, state of the art, State-of-the-Art Percutaneous Coronary Intervention, Coronary-Artery Bypass Grafting, Diabetes Mellitus

Eligibility Criteria

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

Inclusion Criteria: The subject must be ≥20 years of age with angina and/or evidence of myocardial ischemia Patients with type 2 diabetes based on the need for treatment with insulin or oral hypoglycemic drugs or a confirmed elevated blood glucose level (fasting plasma glucose elevation on >1 occasion of ≥126 mg/dL [7.0 mmol/L] or 2-h postprandial of ≥200 mg/dL [11.1 mmol/L] during oral glucose tolerance test or random plasma glucose of ≥200 mg/dL [11.1 mmol/L] with classic symptoms of hyperglycemia or hyperglycemic crisis or HbA1C ≥6.5% [48 mmol/mol]) (17). Significant multivessel CAD (defined as ≥ 50% diameter stenosis by visual estimation) of major epicardial vessels with LAD involvement and amenable to revascularization (equally suitable) by both PCI and CABG as determined by the Heart Team. The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site. Exclusion Criteria: Unprotected left main coronary artery disease requiring revascularization The presence of complex coronary disease anatomy or lesion characteristics or other cardiac condition(s) which leads the participating interventional cardiologist to believe that PCI is not suitable (i.e. the subject should be managed with CABG or medical therapy alone) Recent ST-elevation myocardial infarction(<5 days prior to randomization) Cardiogenic shock and/or need for mechanical/pharmacologic hemodynamic support Severe left ventricular dysfunction (ejection fraction <30%) Requirement for other cardiac or non-cardiac surgical procedure (e.g., valve replacement, aorta surgery, or carotid revascularization). However, a maze procedure or pulmonary vein isolation is allowed Contraindication or inability to take aspirin or P2Y12 inhibitors (clopidogrel, ticagrelor, or clopidogrel) for at least 6 months Prior CABG Extremely calcified or tortuous vessels precluding FFR measurement or intracoronary imaging evaluation More than one major epicardial vessel which is chronically occluded; enrollment of 1 Chronic total occlusion lesion is allowed Subjects requiring or who may require additional surgery (cardiac or noncardiac) within 1 year End-stage renal disease requiring renal replacement therapy Liver cirrhosis Pregnant and/or lactating women. Concurrent medical condition with a limited life expectancy of less than 2 years Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period, except for observational registries

Sites / Locations

  • Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Imaging- and Physiology-Guided State-of-the-Art Percutaneous Coronary Intervention

Coronary-Artery Bypass Grafting

Arm Description

Outcomes

Primary Outcome Measures

The event rate of major adverse cardiac or cerebrovascular events
Major adverse cardiac or cerebrovascular events (MACCE) were defined as a composite of hard clinical endpoints of death from any causes, myocardial infarction, or stroke.

Secondary Outcome Measures

The event rate of death from any cause
The event rate of myocardial infarction
The event rate of stroke
The event rate of composite of death from any causes, cardiovascular causes, or noncardiovascular causes
The event rate of myocardial infarction
any, spontaneous or procedural
The event rate of composite of death or myocardial infarction
The event rate of composite of death, myocardial infarction, stroke or repeat revascularization
The event rate of stent thrombosis
by an Academic Research Consortium (ARC) definition
The event rate of symptomatic graft occlusion or stenosis
The event rate of bleeding complications
BARC (Bleeding Academic Research Consortium) criteria
The event rate of periprocedural major adverse events
Periprocedural major adverse events means major arrhythmia, any unplanned surgery or therapeutic radiologic procedure, development of acute renal failure, sternal wound dehiscence, infection requiring antibiotics, prolonged intubation (>48 hours), post-pericardiotomy syndrome, etc.
Length of hospital stay
The event rate of rehospitalization
any, cardiac, or noncardiac causes
The change of functional class
Assessed by The Canadian Cardiovascular Society (CCS) Angina Score Classification. The minimum and maximum values are 1 and 4 respectively. A higher score of CCS angina score classification means severe exertional angina.
The change of angina-related quality of life index by the Seattle Angina Questionnaire [SAQ]
The SAQ is a disease-specific patient-reported outcome (PRO) with 5 domains. The minimum and maximum values are 0 and 100 respectively. A lower score represents poor health status and a high score represents good health status.
The change of angina-related quality of life index by the EQ-5D
EQ-5D is a standardised measure of health-related quality of life developed by the EuroQol Group. The minimum and maximum values are 5 and 15 respectively. A higher score of EQ-5D means a low quality of life.
The number of anti-anginal medications used

Full Information

First Posted
April 4, 2023
Last Updated
September 19, 2023
Sponsor
Duk-Woo Park, MD
Collaborators
CardioVascular Research Foundation, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT05831085
Brief Title
Diabetes-Centered Evaluation of Revascularization Strategy of Functional and Imaging-CombiNEd State-of-the-Art Percutaneous Coronary Intervention or Coronary-Artery Bypass Grafting in Patients With Diabetes Mellitus and Multivessel Coronary Artery Disease
Acronym
DEFINE-DM
Official Title
A Comparison of Imaging- and Physiology-Guided State-of-the-Art Percutaneous Coronary Intervention and Coronary-Artery Bypass Grafting in Patients With Diabetes and Three-Vessel Coronary Artery Disease: DEFINE-DM Trial (Diabetes-Centered Evaluation of Revascularization Strategy of Functional and Imaging-CombiNEd State-of-the-Art Percutaneous Coronary Intervention or Coronary-Artery Bypass Grafting in Patients With Diabetes Mellitus and Multivessel Coronary Artery Disease)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
June 2027 (Anticipated)
Study Completion Date
December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Duk-Woo Park, MD
Collaborators
CardioVascular Research Foundation, Korea

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
The objective of this randomized study was to compare outcomes of imaging-and physiology-guided state-of-the-art Percutaneous coronary intervention (PCI) to coronary artery bypass grafting (CABG) in patients with diabetes and multivessel coronary artery disease(CAD) with left anterior descending(LAD) involvement.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Stenosis
Keywords
Multivessel Coronary Artery Disease, state of the art, State-of-the-Art Percutaneous Coronary Intervention, Coronary-Artery Bypass Grafting, Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1290 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Imaging- and Physiology-Guided State-of-the-Art Percutaneous Coronary Intervention
Arm Type
Experimental
Arm Title
Coronary-Artery Bypass Grafting
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
State-of-the-Art Percutaneous Coronary Intervention
Intervention Description
supported by intracoronary imaging (e.g., intravascular ultrasound (IVUS) or optical coherence tomography [OCT]), intracoronary physiology (e.g., fractional flow reserve [FFR] or instantaneous wave-free ratio [iFR]), contemporary metallic drug-eluting stents (DES), guideline-directed optimal medical therapy [GDMT] with advanced cardiovascular and anti-diabetic medications [e.g., a sodium-glucose cotransporter [SGLT]-2 inhibitors]) in patients with type 2 diabetes and multivessel coronary artery disease (CAD) with involvement of left anterior descending (LAD)
Intervention Type
Procedure
Intervention Name(s)
standard CABG
Intervention Description
Coronary-Artery Bypass Grafting
Primary Outcome Measure Information:
Title
The event rate of major adverse cardiac or cerebrovascular events
Description
Major adverse cardiac or cerebrovascular events (MACCE) were defined as a composite of hard clinical endpoints of death from any causes, myocardial infarction, or stroke.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
The event rate of death from any cause
Time Frame
2 years
Title
The event rate of myocardial infarction
Time Frame
2 years
Title
The event rate of stroke
Time Frame
2 years
Title
The event rate of composite of death from any causes, cardiovascular causes, or noncardiovascular causes
Time Frame
2 years
Title
The event rate of myocardial infarction
Description
any, spontaneous or procedural
Time Frame
2 years
Title
The event rate of composite of death or myocardial infarction
Time Frame
2 years
Title
The event rate of composite of death, myocardial infarction, stroke or repeat revascularization
Time Frame
2 years
Title
The event rate of stent thrombosis
Description
by an Academic Research Consortium (ARC) definition
Time Frame
2 years
Title
The event rate of symptomatic graft occlusion or stenosis
Time Frame
2 years
Title
The event rate of bleeding complications
Description
BARC (Bleeding Academic Research Consortium) criteria
Time Frame
2 years
Title
The event rate of periprocedural major adverse events
Description
Periprocedural major adverse events means major arrhythmia, any unplanned surgery or therapeutic radiologic procedure, development of acute renal failure, sternal wound dehiscence, infection requiring antibiotics, prolonged intubation (>48 hours), post-pericardiotomy syndrome, etc.
Time Frame
2 years
Title
Length of hospital stay
Time Frame
7 days
Title
The event rate of rehospitalization
Description
any, cardiac, or noncardiac causes
Time Frame
7 days
Title
The change of functional class
Description
Assessed by The Canadian Cardiovascular Society (CCS) Angina Score Classification. The minimum and maximum values are 1 and 4 respectively. A higher score of CCS angina score classification means severe exertional angina.
Time Frame
1, 6, 12,18, 24 months
Title
The change of angina-related quality of life index by the Seattle Angina Questionnaire [SAQ]
Description
The SAQ is a disease-specific patient-reported outcome (PRO) with 5 domains. The minimum and maximum values are 0 and 100 respectively. A lower score represents poor health status and a high score represents good health status.
Time Frame
1, 6, 12,18, 24 months
Title
The change of angina-related quality of life index by the EQ-5D
Description
EQ-5D is a standardised measure of health-related quality of life developed by the EuroQol Group. The minimum and maximum values are 5 and 15 respectively. A higher score of EQ-5D means a low quality of life.
Time Frame
1, 6, 12,18, 24 months
Title
The number of anti-anginal medications used
Time Frame
1, 6, 12,18, 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The subject must be ≥20 years of age with angina and/or evidence of myocardial ischemia Patients with type 2 diabetes based on the need for treatment with insulin or oral hypoglycemic drugs or a confirmed elevated blood glucose level (fasting plasma glucose elevation on >1 occasion of ≥126 mg/dL [7.0 mmol/L] or 2-h postprandial of ≥200 mg/dL [11.1 mmol/L] during oral glucose tolerance test or random plasma glucose of ≥200 mg/dL [11.1 mmol/L] with classic symptoms of hyperglycemia or hyperglycemic crisis or HbA1C ≥6.5% [48 mmol/mol]) (17). Significant multivessel CAD (defined as ≥ 50% diameter stenosis by visual estimation) of major epicardial vessels with LAD involvement and amenable to revascularization (equally suitable) by both PCI and CABG as determined by the Heart Team. The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site. Exclusion Criteria: Unprotected left main coronary artery disease requiring revascularization The presence of complex coronary disease anatomy or lesion characteristics or other cardiac condition(s) which leads the participating interventional cardiologist to believe that PCI is not suitable (i.e. the subject should be managed with CABG or medical therapy alone) Recent ST-elevation myocardial infarction(<5 days prior to randomization) Cardiogenic shock and/or need for mechanical/pharmacologic hemodynamic support Severe left ventricular dysfunction (ejection fraction <30%) Requirement for other cardiac or non-cardiac surgical procedure (e.g., valve replacement, aorta surgery, or carotid revascularization). However, a maze procedure or pulmonary vein isolation is allowed Contraindication or inability to take aspirin or P2Y12 inhibitors (clopidogrel, ticagrelor, or clopidogrel) for at least 6 months Prior CABG Extremely calcified or tortuous vessels precluding FFR measurement or intracoronary imaging evaluation More than one major epicardial vessel which is chronically occluded; enrollment of 1 Chronic total occlusion lesion is allowed Subjects requiring or who may require additional surgery (cardiac or noncardiac) within 1 year End-stage renal disease requiring renal replacement therapy Liver cirrhosis Pregnant and/or lactating women. Concurrent medical condition with a limited life expectancy of less than 2 years Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period, except for observational registries
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jung-hee Ham, Project manager
Phone
82-2-3010-4728
Email
cvcrc5@amc.seoul.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seung-jung Park, MD
Organizational Affiliation
Asan Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Diabetes-Centered Evaluation of Revascularization Strategy of Functional and Imaging-CombiNEd State-of-the-Art Percutaneous Coronary Intervention or Coronary-Artery Bypass Grafting in Patients With Diabetes Mellitus and Multivessel Coronary Artery Disease

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