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

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ClinicalTrials.gov Identifier: NCT01123291
Recruitment Status : Completed
First Posted : May 14, 2010
Last Update Posted : March 15, 2017
Sponsor:
Information provided by (Responsible Party):
Takeshi Morimoto, Kyoto University, Graduate School of Medicine

Brief Summary:
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 or disease Intervention/treatment Phase
Coronary Artery Disease Procedure: follow-up coronary angiography Procedure: Clinical follow-up Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized Evaluation of Routine Follow-up Coronary Angiography After Percutaneous Coronary Intervention Trial
Actual Study Start Date : May 2010
Primary Completion Date : October 2016
Study Completion Date : October 2016

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. a composite of death/myocardial infarction/stroke/emergency hospitalization for acute coronary syndrome/hospitalization for congestive heart failure [ Time Frame: 4.8 years ]
    a composite of death/myocardial infarction/stroke/emergency hospitalization for acute coronary syndrome/hospitalization for congestive heart failure


Secondary Outcome Measures :
  1. death [ Time Frame: 4.8 years ]
    death

  2. cardiac death [ Time Frame: 4.8 years ]
    cardiac death

  3. myocardial infarction [ Time Frame: 4.8 years ]
    myocardial infarction

  4. stent thrombosis [ Time Frame: 4.8 years ]
    stent thrombosis defined bya Academic Reseach Consortium

  5. stroke [ Time Frame: 4.8 years ]
    both ischemic and hemorrhagic stroke excluding transient ischemic attach

  6. bleeding complications [ Time Frame: 4.8 years ]
    bleeding complications defined by GUSTO and TIMI

  7. any coronary revascularization [ Time Frame: 4.8 years ]
    any coronary revascularization

  8. clinically-driven coronary revascularization [ Time Frame: 4.8 years ]
    clinically-driven coronary revascularization

  9. clinically-driven target-lesion revascularization [ Time Frame: 4.8 years ]
    clinically-driven target-lesion revascularization

  10. any target-lesion revascularization [ Time Frame: 4.8 years ]
    any target-lesion revascularization

  11. coronary artery bypass grafting [ Time Frame: 4.8 years ]
    coronary artery bypass grafting

  12. angina [ Time Frame: 4.8 years ]
    angina

  13. renal function [ Time Frame: 4.8 years ]
    estimate-glomerular filtration rate

  14. emergency hospitalization for acute coronary syndrome [ Time Frame: 4.8 years ]
    emergency hospitalization for acute coronary syndrome

  15. hospitalization for congestive heart failure [ Time Frame: 4.8 years ]
    hospitalization for congestive heart failure

  16. composite of cardiac death, myocardial infarction or acute coronary syndrome [ Time Frame: 4.8 years ]
    composite of cardiac death, myocardial infarction or acute coronary syndrome

  17. follow-up coronary angiography [ Time Frame: 4.8 years ]
    presence of follow-up coronary angiography

  18. clinically-driven follow-up coronary angiography [ Time Frame: 4.8 years ]
    presence of clinically-driven follow-up coronary angiography



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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01123291


Locations
Japan
Division of Cardiology, Kyoto University Hospital
Kyoto, Japan, 606-8507
Sponsors and Collaborators
Takeshi Morimoto
Investigators
Principal Investigator: Takeshi Kimura, MD Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Takeshi Morimoto, Professor, Kyoto University, Graduate School of Medicine
ClinicalTrials.gov Identifier: NCT01123291     History of Changes
Other Study ID Numbers: C406
First Posted: May 14, 2010    Key Record Dates
Last Update Posted: March 15, 2017
Last Verified: March 2017

Keywords provided by Takeshi Morimoto, 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