Prospective Evaluation of MyocaRdial PerFUSion ComputEd Tomography Trial (PERFUSE RCT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by Asan Medical Center
Sponsor:
Information provided by (Responsible Party):
Young-Hak Kim, MD, PhD, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT02208388
First received: July 31, 2014
Last updated: March 16, 2015
Last verified: March 2015
  Purpose

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


Condition Intervention Phase
Coronary Disease
Device: computed tomography perfusion guided treatment
Device: Fractional flow reserve guided treatment
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Evaluation of MyocaRdial PerFUSion ComputEd Tomography Trial: Ischemia-guided Revascularization Using Perfusion Coronary CT vs. Fractional Flow Reserve

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Composite Events [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    All cause death, Myocardial infarction, Diseased-related unplanned hospitalization or stroke


Secondary Outcome Measures:
  • All cause death [ Time Frame: 5 year ] [ Designated as safety issue: Yes ]
  • Myocardial infarction [ Time Frame: 5 year ] [ Designated as safety issue: Yes ]
  • Target vessel revascularization [ Time Frame: 5 year ] [ Designated as safety issue: Yes ]
  • Stent thrombosis [ Time Frame: 5 year ] [ Designated as safety issue: Yes ]
  • Quality of Life [ Time Frame: 5 year ] [ Designated as safety issue: No ]
    Using Seattle Angina Questionnaire, EQ5D questionnaire

  • Success of intervention [ Time Frame: 5 year ] [ Designated as safety issue: No ]
    Success of intervention is evaluated from number of used stents, the time required, fluoroscopic time, quantity of contrast media compositely,

  • Cost effective analysis [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: August 2014
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Computed tomography perfusion Device: computed tomography perfusion guided treatment
Active Comparator: Fractional flow reserve Device: Fractional flow reserve guided treatment

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02208388

Contacts
Contact: Young-Hak Kim, MD mdyhkim@amc.seoul.kr

Locations
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Songpa-Gu, Korea, Republic of
Contact: Young-Hak Kim, MD, PhD    82-2-3010-3955    mdyhkim@amc.seoul.kr   
Principal Investigator: Young-Hak Kim, MD,PhD         
Hallym University Sacred Heart Hospital Recruiting
Anyang, Korea, Republic of
Contact: Hyun-Sook Kim, MD       heartsk@hotmail.com   
Principal Investigator: Hyun-Sook Kim, MD         
Gangwon National Univ. Hospital Recruiting
Chuncheon, Korea, Republic of
Contact: Bong-Ki Lee, MD       mdbklee@kangwon.ac.kr   
Principal Investigator: Bong-Ki Lee, MD         
Keimyung University Dongsan Medical Center Not yet recruiting
Daegu, Korea, Republic of
Contact: Seung-Ho Hur, MD       shur@dsmc.or.kr   
Principal Investigator: Seung-Ho Hur, MD         
Konyang University Hospital Not yet recruiting
Daejeon, Korea, Republic of
Contact: Jang-Ho Bae, MD       jhbae@kyuh.co.kr   
Principal Investigator: Jang-Ho Bae, MD         
The Catholic University of Korea, Daejeon ST. Mary's Hospital Recruiting
Daejeon, Korea, Republic of
Contact: Sung-Ho Her, MD       hhhsungho@naver.com   
Principal Investigator: Sung-Ho Her, MD         
Chungnam National University Hospital Recruiting
Daejeon, Korea, Republic of
Contact: Jae-Hwan Lee, MD       myheart@cnu.ac.kr   
Principal Investigator: Jae-Hwan Lee, MD         
ChonBuk National University Hospital Recruiting
Jeonju, Korea, Republic of
Contact: Jei-Keon Chae, MD       jkchae@chonbuk.ac.kr   
Principal Investigator: Jei-Keon Chae, MD         
Pusan National University Hospital Recruiting
Pusan, Korea, Republic of
Contact: Joon-Hyuk Oh, MD       jhoh724@hanmail.net   
Principal Investigator: Joon-Hyuk Oh, MD         
Pusan National University Yangsan Hospital Recruiting
Pusan, Korea, Republic of
Contact: Sang-Hyun Lee, MD         
Principal Investigator: Sang-Hyun Lee, MD         
Severance Hospital Recruiting
Seoul, Korea, Republic of
Contact: Byoung-Wook Choi, MD         
Principal Investigator: Byoung-Wook Choi, MD         
The Catholic University of Korea Seoul St. Mary's Hospital Recruiting
Seoul, Korea, Republic of
Contact: Pum-Joon Kim, MD       bjheart@catholic.ac.kr   
Principal Investigator: Pum-Joon Kim, MD         
Ulsan University Hospital Recruiting
Ulsan, Korea, Republic of
Contact: Eun-Seok Shin, MD       sesim98@yahoo.co.kr   
Principal Investigator: Eun-Seok Shin, MD         
Sponsors and Collaborators
Young-Hak Kim, MD, PhD
Investigators
Principal Investigator: Byoung-Wook Choi, MD Severance Hospital, Yonsei University College of Medicine
Principal Investigator: Young-Hak Kim, MD Asan Medical Center
  More Information

No publications provided

Responsible Party: Young-Hak Kim, MD, PhD, MD, Asan Medical Center
ClinicalTrials.gov Identifier: NCT02208388     History of Changes
Other Study ID Numbers: AMCCV2014-06
Study First Received: July 31, 2014
Last Updated: March 16, 2015
Health Authority: Korea: Institutional Review Board

Keywords provided by Asan Medical Center:
Computed tomography perfusion
Fractional flow reserve

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Myocardial Ischemia
Vascular Diseases

ClinicalTrials.gov processed this record on July 30, 2015