Study of the Natural History of FFR Guided Percutaneous Coronary Intervention (IRIS FFR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by CardioVascular Research Foundation, Korea
Sponsor:
Collaborators:
CardioVascular Research Foundation, Korea
St. Jude Medical (Hong Kong) Limited
Information provided by (Responsible Party):
Seung-Jung Park, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier:
NCT01366404
First received: June 2, 2011
Last updated: February 5, 2016
Last verified: February 2016
  Purpose
About 10,000 patients with FFR (Fractional Flow Reserve) will be enrolled and evaluated for the natural history of coronary lesions at 2 year clinical and imaging follow-up.

Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multicenter, Prospective Cohort to Evaluate the Natural History of FFR Guided Percutaneous Coronary Intervention

Further study details as provided by CardioVascular Research Foundation, Korea:

Primary Outcome Measures:
  • Target vessel failure [ Time Frame: 2 year after index FFR measurement ] [ Designated as safety issue: Yes ]
  • composite Cardiac Death,Non Fatal Myocardial Infarction, Target Vessel Revascularization, and Indeterminate events [ Time Frame: at 2 year after index FFR measurement ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Death (all cause and cardiac) [ Time Frame: at 2 year after index FFR measurement ] [ Designated as safety issue: Yes ]
  • MI [ Time Frame: at 2 year after index FFR measurement ] [ Designated as safety issue: Yes ]
  • Target vessel revascularization [ Time Frame: at 2 year after index FFR measurement ] [ Designated as safety issue: No ]
  • Target lesion revascularization [ Time Frame: at 2 year after index FFR measurement ] [ Designated as safety issue: No ]
  • Any re-hospitalization with a cardiac cause [ Time Frame: 2 year follow-up after index FFR measurement ] [ Designated as safety issue: Yes ]
  • cardiac death and myocardial infarction [ Time Frame: 2 year follow-up after index FFR measurement ] [ Designated as safety issue: Yes ]
  • stented lesion related event including death, myocardial infarction, repeat revascularization [ Time Frame: 2 year follow-up after index FFR measurement ] [ Designated as safety issue: Yes ]
  • stroke [ Time Frame: 2 year follow-up after index FFR measurement ] [ Designated as safety issue: Yes ]
  • stent thrombosis [ Time Frame: 2 year follow-up after index FFR measurement ] [ Designated as safety issue: Yes ]
  • anginal status [ Time Frame: 2 year follow-up after index FFR measurement ] [ Designated as safety issue: Yes ]
  • number of anti-anginal medication prescribed [ Time Frame: 2 year follow-up after index FFR measurement ] [ Designated as safety issue: No ]
  • complication of FFR measurement [ Time Frame: 2 year follow-up after index FFR measurement ] [ Designated as safety issue: No ]
  • clinical predictors of events [ Time Frame: 2 year follow-up after index FFR measurement ] [ Designated as safety issue: Yes ]
  • change in plaque composition (%necrotic core volume) in target segment [ Time Frame: 2 year follow-up after index FFR measurement ] [ Designated as safety issue: No ]
  • change in plaque type assessed by VH(Virtual Histology) and OCT(Optical coherence tomography) [ Time Frame: 2 year follow-up after index FFR measurement ] [ Designated as safety issue: No ]
  • change in total atheroma volume and percent atheroma volume [ Time Frame: 2 year follow-up after index FFR measurement ] [ Designated as safety issue: No ]
  • change in IVUS-measured MLA [ Time Frame: 2 year follow-up after index FFR measurement ] [ Designated as safety issue: No ]
  • change in FFR [ Time Frame: 2 year follow-up after index FFR measurement ] [ Designated as safety issue: No ]

Estimated Enrollment: 10000
Study Start Date: June 2011
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
FFR
Patients who had FFR measurement

Detailed Description:
This is a multicenter, prospective cohort. About 10,000 patients with FFR will be enrolled at multi centers in Korea.
  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who had FFR measurement
Criteria

Inclusion Criteria:

  • Age 35 years and older
  • FFR measurement on one and more coronary artery stenosis
  • Willing and able to provide informed, written consent

Exclusion Criteria:

  • Stenosis with TIMI<3 flow
  • Graft vessel
  • Ejection fraction < 30%
  • Angiographic evidence of extreme tortuosity or calcified coronary vessels
  • Suspected coronary spasm even after sufficient nitrate injected
  • Life expectancy <2 year
  • Planned cardiac surgery or planned major non cardiac surgery
  • Woman who are breastfeeding, pregnant or planning to become pregnant during the course of the study

Imaging study specific exclusion criteria

  • visually-estimated angiographic reference segment diameter of <2.75mm or >4.0mm
  • Inappropriate for IVUS/VH/OCT procedures : inability for imaging wire or catheter to pass through the tight stenosis, severe calcification, angulation
  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: NCT01366404

Contacts
Contact: Seung-Jung Park, MD, PhD sjpark@amc.seoul.kr
Contact: Jung-min Ahn, MD drjmahn@gmail.com

Locations
Korea, Republic of
Hallym University Sacred Heart Hospital Recruiting
Anyang, Korea, Republic of
Contact: Hyun-sook Kim, MD       heartsk@hotmail.com   
Principal Investigator: Hyun-sook Kim, MD         
Soon Chun Hyang University Hospital Bucheon Recruiting
Bucheon, Korea, Republic of
Contact: Nae-hee Lee, MD       naeheelee@naver.com   
Principal Investigator: Nae-hee Lee, MD         
Chungbuk National University Hospital Recruiting
Cheongju, Korea, Republic of
Contact: Sang-yeub Lee, MD       louisahj@naver.com   
Principal Investigator: Sang-yeub Lee, MD         
Gangwon National Univ. Hospital Recruiting
Chuncheon, Korea, Republic of
Contact: Bong-ki Lee, MD       mdbklee@kangwon.ac.kr   
Principal Investigator: Bong-ki Kim, MD         
Daegu Catholic University Center Recruiting
Daegu, Korea, Republic of
Contact: Jin-bae Lee, MD       jblee@cu.ac.kr   
Principal Investigator: Jin-bae Lee, MD         
Keimyung University Dongsan Medical Center Recruiting
Daegu, Korea, Republic of
Contact: Chang-wook Nam, MD       ncwcv@dsmc.or.kr   
Principal Investigator: Chang-wook Nam, MD         
Kyungpook National university hospital Recruiting
Daegu, Korea, Republic of
Contact: Hun-sik Park, MD       hspark@knu.ac.kr   
Principal Investigator: Hun-sik Park, MD         
Yeungnam University Medical Center Recruiting
Daegu, Korea, Republic of
Contact: Jong-seon Park, MD       pjs@med.yu.ac.kr   
Principal Investigator: Jong-seon Park, MD         
The Catholic University of Korea, Deajeon 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
Deajeon, Korea, Republic of
Contact: Si-wan Choi, MD       siwanc@cnu.ac.kr   
Principal Investigator: Si-wan Choi, MD         
Gangneung Asan Hospital Recruiting
Gangneung, Korea, Republic of
Contact: Sang-sig Cheong, MD       sscheong@gnah.co.kr   
Principal Investigator: Sang-sig Cheong, MD         
Chonnam National University Hospital Recruiting
Gwangju, Korea, Republic of
Contact: Young-jun Hong, MD       hyj200@hanmail.net   
Principal Investigator: Young-jun Hong, MD         
Inje University Ilsan Paik Hospital Recruiting
Ilsan, Korea, Republic of
Contact: Joon-hyung Doh, MD       joon.doh@gmail.com   
Principal Investigator: Joon-hyung Doh, MD         
National Health Insurance Service Ilsan Hospital Recruiting
Ilsan, Korea, Republic of
Contact: Joo-young Yang, MD       jooyy11@paran.com   
Principal Investigator: Joo-young Yang, MD         
Dong-A Medical Center Recruiting
Pusan, Korea, Republic of
Contact: Kyung-il Park, MD       cardiopark@gmail.com   
Principal Investigator: Kyung-il Park, MD         
Pusan National University Hospital Recruiting
Pusan, Korea, Republic of
Contact: Taeg-jong Hong, MD       md-phd@hanmail.net   
Principal Investigator: Taeg-jong Hong, MD         
The Catholic University of Korea, Yeouido St. Mary's Hospital Recruiting
Seoul, Korea, Republic of
Contact: Chul-soo Park, MD       charlie@catholic.ac.kr   
Principal Investigator: Chul-soo Park, MD         
Gangnam Severance Hospital Recruiting
Seoul, Korea, Republic of
Contact: Byoung-kwon Lee, MD       cardiobk@yuhs.ac   
Principal Investigator: Byoung-kwon Lee, MD         
Hallym University Kangdong Sacred Heart Hospital Recruiting
Seoul, Korea, Republic of
Contact: Kyoo-rok Han, MD       krheart@hallym.or.kr   
Principal Investigator: Kyoo-rok Han, MD         
Korea University Anam Hospital Recruiting
Seoul, Korea, Republic of
Contact: Do-sun Lim, MD       dslmd@kumc.or.kr   
Principal Investigator: Do-sun Lim, MD         
Korea University Guro Hospital Recruiting
Seoul, Korea, Republic of
Contact: Seung-un Na, MD       swrha617@yahoo.co.kr   
Principal Investigator: Seung-un Na, MD         
Kyung-Hee University Hospital at Kangdong Recruiting
Seoul, Korea, Republic of
Contact: Jong-jin Kim, MD       chongjinkim@naver.com   
Principal Investigator: Jong-jin Kim, MD         
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Seung-jung Park, MD       sjpark@amc.seoul.kr   
Principal Investigator: Seung-jung Park, MD         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Bon-kwon Koo, MD       bkkoo@snu.ac.kr   
Principal Investigator: Bon-kwon Koo, MD         
The Catholic University of Korea, Seoul St.Mary's Hospital Recruiting
Seoul, Korea, Republic of
Contact: Ki-bae Seung, MD       kbseung@catholic.ac.kr   
Principal Investigator: Ki-bae Seung, MD         
Seoul National University Boramae Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Woo-young Chung, MD       Chungwy3023@gmail.com   
Principal Investigator: Woo-young Chung, MD         
Seoul university Bundang hospital Recruiting
Sungnam, Korea, Republic of
Contact: In-ho Chae, MD       ihchae@snu.ac.kr   
Principal Investigator: In-ho Chae, MD         
Ulsan University Hospital Recruiting
Ulsan, Korea, Republic of
Contact: Eun-seok Shin, MD       sesim1989@gmail.com   
Principal Investigator: Eun-seok Shin, MD         
Wonju Severance Christian Hospital Recruiting
Wonju, Korea, Republic of
Contact: Jung-han Yoon, MD       jyoon@yonsei.ac.kr   
Principal Investigator: Jung-han Yoon, MD         
Pusan National University Yangsan Hospital Recruiting
Yangsan, Korea, Republic of
Contact: Jun-hong Kim, MD       junehongk@gmail.com   
Principal Investigator: Jun-hong Kim, MD         
Sponsors and Collaborators
Seung-Jung Park
CardioVascular Research Foundation, Korea
St. Jude Medical (Hong Kong) Limited
Investigators
Principal Investigator: Seung-Jung Park, MD,PhD Asan Medical Center
  More Information

No publications provided by CardioVascular Research Foundation, Korea

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Seung-Jung Park, MD,PhD, Chairman of Heart Institution, Asan Medical Center, University of Ulsan College of Medicine, CardioVascular Research Foundation, Korea
ClinicalTrials.gov Identifier: NCT01366404     History of Changes
Other Study ID Numbers: CVRF2010-09 
Study First Received: June 2, 2011
Last Updated: February 5, 2016
Health Authority: Korea: Institutional Review Board

Keywords provided by CardioVascular Research Foundation, Korea:
FFR

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

ClinicalTrials.gov processed this record on February 11, 2016