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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2014 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: August 7, 2014
Last verified: August 2014
  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: Safety 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: Yes ]
    All cause death, Myocardial infarction, unscheduled hospitalization


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 symptom or objective evidence of myocardial ischemia
  • 70 % and more coronary stenosis on computed tomography angiography

Exclusion Criteria:

  • Major surgery including coronary artery bypass graft
  • Unstable medical condition
  • renal disorder
  • prior enrollment in other randomized study
  • Pregnant or lactating woman
  • Left main stenosis
  • complicated lesion(long, calcification)
  • Restenosis
  • History of percutaneous coronary intervention with stent
  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
Seoul, Songpa-Gu, Korea, Republic of
Hallym University Sacred Heart Hospital Not yet recruiting
Anyang, Korea, Republic of
Contact: Hyun-Sook Kim, MD       heartsk@hotmail.com   
Principal Investigator: Hyun-Sook Kim, MD         
Gangwon National Univ. Hospital Not yet 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         
Daegu Catholic University Medical Center Not yet recruiting
Daegu, Korea, Republic of
Contact: Jin-Bae Lee, MD       jblee@cu.ac.kr   
Principal Investigator: Jin-Bae Lee, 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 Not yet recruiting
Daejeon, Korea, Republic of
Contact: Sung-Ho Her, MD       hhhsungho@naver.com   
Principal Investigator: Sung-Ho Her, MD         
Chungnam National University Hospital Not yet recruiting
Daejeon, Korea, Republic of
Contact: Jae-Hwan Lee, MD       myheart@cnu.ac.kr   
Principal Investigator: Jae-Hwan Lee, MD         
Dongtan Sacred Heart Hospital Not yet recruiting
Hwaseong, Korea, Republic of
Contact: Min-Kyu Kim, MD       cagkim@medimail.co.kr   
Principal Investigator: Min-Kyu Kim, MD         
National Health Insurance Corporation Ilsan Hospital Not yet recruiting
Ilsan, Korea, Republic of
Contact: Sung-Jin Oh, MD       osjwsa@dreamwiz.com   
Principal Investigator: Sung-Jin Oh, MD         
ChonBuk National University Hospital Not yet recruiting
Jeonju, Korea, Republic of
Contact: Jei-Keon Chae, MD       jkchae@chonbuk.ac.kr   
Principal Investigator: Jei-Keon Chae, MD         
Pusan National University Hospital Not yet recruiting
Pusan, Korea, Republic of
Contact: Joon-Hyuk Oh, MD       jhoh724@hanmail.net   
Principal Investigator: Joon-Hyuk Oh, MD         
Pusan National University Yangsan Hospital Not yet recruiting
Pusan, Korea, Republic of
Contact: Sang-Hyun Lee, MD         
Principal Investigator: Sang-Hyun Lee, MD         
Seoul National University hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Bon-Kwon Koo, MD       bkkoo@snu.ac.kr   
Principal Investigator: Bon-Kwon Koo, MD         
Severance Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Byoung-Wook Choi, MD         
Principal Investigator: Byoung-Wook Choi, MD         
Konguk University Medical Center Not yet recruiting
Seoul, Korea, Republic of
Contact: Heung-Kon Hwang, MD       h_k_hwang@hotmail.com   
Principal Investigator: Heung-Kon Hwang, MD         
The Catholic University of Korea Seoul St. Mary's Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Pum-Joon Kim, MD       bjheart@catholic.ac.kr   
Principal Investigator: Pum-Joon Kim, MD         
Korea University Anam Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Soon-Jun Hong, MD       psyche94@hanmail.net   
Principal Investigator: Soon-Jun Hong, MD         
Ajou University Hospital Not yet recruiting
Suwon, Korea, Republic of
Contact: Myoung-Ho Yoon, MD         
Principal Investigator: Myoung-Ho Yoon, MD         
Ulsan University Hospital Not yet 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: August 7, 2014
Health Authority: Korea: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 16, 2014