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

This study is currently recruiting participants.
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
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 April 17, 2014