search
Back to results

Prospective Evaluation of MyocaRdial PerFUSion ComputEd Tomography Trial (PERFUSERCT)

Primary Purpose

Coronary Disease

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
computed tomography perfusion guided treatment
Fractional flow reserve guided treatment
Sponsored by
Young-Hak Kim, MD, PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Disease focused on measuring Computed tomography perfusion, Fractional flow reserve

Eligibility Criteria

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

Inclusion Criteria:

  • Age 20 and more
  • Diagnosed angina or angina equivalent symptom or positive exercise treadmill test
  • Patients with intermediate- or high-risk probability of CAD defined by Diamond and Forester
  • 70 % stenosis or more in coronary CTA
  • Willing to provide informed, written consent

Exclusion Criteria:

  • Requirement for surgical procedure
  • Cardiogenic shock and/or need for mechanical/pharmacologic hemodynamic support
  • Recent STEMI (<5 days)
  • Non STEMI, if the cardiac troponin is not stable or starting to decline
  • Left ventricular ejection fraction <30%
  • Life expectancy <2 years
  • Impaired renal function with an effective glomerular filtration rate less than 30mL/min/1.73 ㎡ or creatinine more than 2.0 mg/dL
  • Undergoing evaluation for organ transplantation
  • Participation or planned participation in another cardiovascular clinical trial
  • Pregnancy
  • Inability to take dual antiplatelet therapy for six months
  • Previous CABG
  • Left main disease requiring revascularization
  • Any target lesion with in-stent restenosis
  • NYHA class 3 or 4a
  • Severe and persistent angina with severe limitation in everyday living activities (Canadian Cardiovascular Society grading Class IV)

Sites / Locations

  • Asan Medical CenterRecruiting
  • Hallym University Sacred Heart Hospital
  • Gangwon National Univ. Hospital
  • Keimyung University Dongsan Medical Center
  • Pusan National University Hospital
  • Pusan National University Yangsan Hospital
  • Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Computed tomography perfusion

Fractional flow reserve

Arm Description

Patients with Computed tomography perfusion

Patients with Fractional flow reserve

Outcomes

Primary Outcome Measures

Composite Events
All cause death, Myocardial infarction, Diseased-related unplanned hospitalization or stroke

Secondary Outcome Measures

All cause death
All cause death
Myocardial infarction
Myocardial infarction
Target vessel revascularization
Target vessel revascularization
Stent thrombosis
Stent thrombosis
Seattle Angina Questionnaire,EQ5D questionnaire
Quality of life score assessed by the EQ-5D-5L The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Higher score of EQ-5D and EQ VAS means the low quality of life. EQ-5D: the minimum and maximum values are 5 and 25 respectively. EQ VAS: the minimum and maximum values are 0 and 100 respectively. Seattle Angina Questionnaire The Seattle Angina Questionnaire (SAQ) is a vali- dated disease-specific instrument for assessing the health status of patients with coronary artery disease. SAQ scores can be aligned with clinical constructs (eg, scores on the SAQ angina frequency scale of 0-30 points indicate daily angina, 31-60 points indicate weekly angina, 61-99 points indicate monthly angina, and 100 points indicate no angina)
Success of intervention
Defined as mean lesion diameter stenosis ≤50% and without the occurrence of in-hospital myocardial infarction (MI), target vessel revascularization (TVR), or death
Cost effective analysis
Cost effective analysis

Full Information

First Posted
July 31, 2014
Last Updated
April 4, 2023
Sponsor
Young-Hak Kim, MD, PhD
search

1. Study Identification

Unique Protocol Identification Number
NCT02208388
Brief Title
Prospective Evaluation of MyocaRdial PerFUSion ComputEd Tomography Trial
Acronym
PERFUSERCT
Official Title
Prospective Evaluation of MyocaRdial PerFUSion ComputEd Tomography Trial: Ischemia-guided Revascularization Using Perfusion Coronary CT vs. Fractional Flow Reserve
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 12, 2014 (Actual)
Primary Completion Date
March 5, 2028 (Anticipated)
Study Completion Date
March 5, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Young-Hak Kim, MD, PhD

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate safety and effectiveness of CTP(computed tomography perfusion) guided revascularization vs FFR(Fractional flow reserve) guided revascularization

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease
Keywords
Computed tomography perfusion, Fractional flow reserve

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Computed tomography perfusion
Arm Type
Experimental
Arm Description
Patients with Computed tomography perfusion
Arm Title
Fractional flow reserve
Arm Type
Active Comparator
Arm Description
Patients with Fractional flow reserve
Intervention Type
Device
Intervention Name(s)
computed tomography perfusion guided treatment
Intervention Type
Device
Intervention Name(s)
Fractional flow reserve guided treatment
Primary Outcome Measure Information:
Title
Composite Events
Description
All cause death, Myocardial infarction, Diseased-related unplanned hospitalization or stroke
Time Frame
1 year
Secondary Outcome Measure Information:
Title
All cause death
Description
All cause death
Time Frame
5 year
Title
Myocardial infarction
Description
Myocardial infarction
Time Frame
5 year
Title
Target vessel revascularization
Description
Target vessel revascularization
Time Frame
5 year
Title
Stent thrombosis
Description
Stent thrombosis
Time Frame
5 year
Title
Seattle Angina Questionnaire,EQ5D questionnaire
Description
Quality of life score assessed by the EQ-5D-5L The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Higher score of EQ-5D and EQ VAS means the low quality of life. EQ-5D: the minimum and maximum values are 5 and 25 respectively. EQ VAS: the minimum and maximum values are 0 and 100 respectively. Seattle Angina Questionnaire The Seattle Angina Questionnaire (SAQ) is a vali- dated disease-specific instrument for assessing the health status of patients with coronary artery disease. SAQ scores can be aligned with clinical constructs (eg, scores on the SAQ angina frequency scale of 0-30 points indicate daily angina, 31-60 points indicate weekly angina, 61-99 points indicate monthly angina, and 100 points indicate no angina)
Time Frame
5 year
Title
Success of intervention
Description
Defined as mean lesion diameter stenosis ≤50% and without the occurrence of in-hospital myocardial infarction (MI), target vessel revascularization (TVR), or death
Time Frame
5 year
Title
Cost effective analysis
Description
Cost effective analysis
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 20 and more Diagnosed angina or angina equivalent symptom or positive exercise treadmill test Patients with intermediate- or high-risk probability of CAD defined by Diamond and Forester 70 % stenosis or more in coronary CTA Willing to provide informed, written consent Exclusion Criteria: Requirement for surgical procedure Cardiogenic shock and/or need for mechanical/pharmacologic hemodynamic support Recent STEMI (<5 days) Non STEMI, if the cardiac troponin is not stable or starting to decline Left ventricular ejection fraction <30% Life expectancy <2 years Impaired renal function with an effective glomerular filtration rate less than 30mL/min/1.73 ㎡ or creatinine more than 2.0 mg/dL Undergoing evaluation for organ transplantation Participation or planned participation in another cardiovascular clinical trial Pregnancy Inability to take dual antiplatelet therapy for six months Previous CABG Left main disease requiring revascularization Any target lesion with in-stent restenosis NYHA class 3 or 4a Severe and persistent angina with severe limitation in everyday living activities (Canadian Cardiovascular Society grading Class IV)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Young-Hak Kim, MD
Email
mdyhkim@amc.seoul.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Byoung-Wook Choi, MD
Organizational Affiliation
Severance Hospital, Yonsei University College of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Young-Hak Kim, MD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
State/Province
Songpa-Gu
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young-Hak Kim, MD, PhD
Phone
82-2-3010-3955
Email
mdyhkim@amc.seoul.kr
First Name & Middle Initial & Last Name & Degree
Young-Hak Kim, MD,PhD
Facility Name
Hallym University Sacred Heart Hospital
City
Anyang
Country
Korea, Republic of
Individual Site Status
Completed
Facility Name
Gangwon National Univ. Hospital
City
Chuncheon
Country
Korea, Republic of
Individual Site Status
Completed
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
Country
Korea, Republic of
Individual Site Status
Completed
Facility Name
Pusan National University Hospital
City
Pusan
Country
Korea, Republic of
Individual Site Status
Enrolling by invitation
Facility Name
Pusan National University Yangsan Hospital
City
Pusan
Country
Korea, Republic of
Individual Site Status
Completed
Facility Name
Severance Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Withdrawn

12. IPD Sharing Statement

Learn more about this trial

Prospective Evaluation of MyocaRdial PerFUSion ComputEd Tomography Trial

We'll reach out to this number within 24 hrs