Evaluation of Routine Follow-up Coronary Angiography After Percutaneous Coronary Intervention Trial (ReACT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by Kyoto University, Graduate School of Medicine
Sponsor:
Information provided by (Responsible Party):
Takeshi Morimoto, Kyoto University, Graduate School of Medicine
ClinicalTrials.gov Identifier:
NCT01123291
First received: May 13, 2010
Last updated: August 1, 2012
Last verified: August 2012
  Purpose

The purpose of this study is to evaluate the long term clinical impact of routine follow-up coronary angiography after percutaneous coronary intervention (PCI). The primary endpoint is a composite of death/myocardial infarction/stroke/emergency hospitalization for acute coronary syndrome/hospitalization for congestive heart failure at 3-year after percutaneous coronary intervention.


Condition Intervention Phase
Coronary Artery Disease
Procedure: follow-up coronary angiography
Procedure: Clinical follow-up
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Randomized Evaluation of Routine Follow-up Coronary Angiography After Percutaneous Coronary Intervention Trial

Resource links provided by NLM:


Further study details as provided by Kyoto University, Graduate School of Medicine:

Primary Outcome Measures:
  • a composite of death/myocardial infarction/stroke/emergency hospitalization for acute coronary syndrome/hospitalization for congestive heart failure [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    a composite of death/myocardial infarction/stroke/emergency hospitalization for acute coronary syndrome/hospitalization for congestive heart failure


Secondary Outcome Measures:
  • death [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    death

  • cardiac death [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    cardiac death

  • myocardial infarction [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    myocardial infarction

  • stent thrombosis [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    stent thrombosis defined bya Academic Reseach Consortium

  • stroke [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    both ischemic and hemorrhagic stroke excluding transient ischemic attach

  • bleeding complications [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    bleeding complications defined by GUSTO and TIMI

  • any coronary revascularization [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    any coronary revascularization

  • clinically-driven coronary revascularization [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    clinically-driven coronary revascularization

  • clinically-driven target-lesion revascularization [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    clinically-driven target-lesion revascularization

  • any target-lesion revascularization [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    any target-lesion revascularization

  • coronary artery bypass grafting [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    coronary artery bypass grafting

  • angina [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    angina

  • renal function [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    estimate-glomerular filtration rate

  • emergency hospitalization for acute coronary syndrome [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    emergency hospitalization for acute coronary syndrome

  • hospitalization for congestive heart failure [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    hospitalization for congestive heart failure

  • composite of cardiac death, myocardial infarction or acute coronary syndrome [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    composite of cardiac death, myocardial infarction or acute coronary syndrome

  • follow-up coronary angiography [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    presence of follow-up coronary angiography

  • clinically-driven follow-up coronary angiography [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    presence of clinically-driven follow-up coronary angiography


Estimated Enrollment: 3300
Study Start Date: May 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: routine follow-up coronary angiography
routine follow-up coronary angiography at 8-12 after discharge for percutaneous coronary intervention
Procedure: follow-up coronary angiography
follow-up coronary angiography at 8-12 months after discharge for percutaneous coronary intervention
Active Comparator: clinical follow-up
no routine follow-up coronary angiography at 8-12 after discharge for percutaneous coronary intervention
Procedure: Clinical follow-up
no routine follow-up coronary angiography at 8-12 months after discharge for percutaneous coronary intervention

Detailed Description:

Routine follow-up coronary angiography after percutaneous coronary intervention has been performed to detect restenosis in a lot of PCI centers in Japan. On the other hand, previous studies reported that routine follow-up coronary angiography might lead to unnecessary reinterventions in asymptomatic patients. In this situation, the effect of routine follow-up coronary angiography on long-term clinical outcomes remains unknown. The purpose of this study is to evaluate the long-term clinical impact of routine follow-up coronary angiography after PCI compared with clinical follow-up alone. The primary endpoint of this study is a composite of death/myocardial infarction/stroke/emergency hospitalization for acute coronary syndrome/hospitalization for congestive heart failure at three-year after percutaneous coronary intervention. The design of this study is almost all-comer design enrolling patients received PCI without any exclusion criteria.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients received percutaneous coronary intervention
  • Patients older than 20 years old
  • Patients who will not scheduled any staged percutaneous coronary intervention
  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: NCT01123291

Contacts
Contact: Takeshi Kimura, MD +81-75-751-4254 taketaka@kuhp.kyoto-u.ac.jp
Contact: Takeshi Morimoto, MD +81-75-751-4890 office@kuhp.kyoto-u.ac.jp

Locations
Japan
Division of Cardiology, Kyoto University Hospital Recruiting
Kyoto, Japan, 606-8507
Contact: Takeshi Kimura, MD    +81-75-751-4254    taketaka@kuhp.kyoto-u.ac.jp   
Contact: Hiroki Shiomi, MD    +81-75-751-4255    hishiomi@kuhp.kyoto-u.ac.jp   
Principal Investigator: Takeshi Kimura, MD         
Sponsors and Collaborators
Takeshi Morimoto
Investigators
Principal Investigator: Takeshi Kimura, MD Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
  More Information

No publications provided

Responsible Party: Takeshi Morimoto, Professor, Kyoto University, Graduate School of Medicine
ClinicalTrials.gov Identifier: NCT01123291     History of Changes
Other Study ID Numbers: C406
Study First Received: May 13, 2010
Last Updated: August 1, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Kyoto University, Graduate School of Medicine:
follow-up coronary angiography

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

ClinicalTrials.gov processed this record on July 24, 2014