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Completed

NCT Number: NCT01123291

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Division of Cardiology, Kyoto University Hospital

Kyoto, 606-8507, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

follow-up coronary angiography

Procedure

follow-up coronary angiography at 8-12 months after discharge for percutaneous coronary intervention

Clinical follow-up

Procedure

no routine follow-up coronary angiography at 8-12 months after discharge for percutaneous coronary intervention

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Takeshi Morimoto

Other

Registry information

Official study title

Randomized Evaluation of Routine Follow-up Coronary Angiography After Percutaneous Coronary Intervention Trial

Acronym: ReACT

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
May 14, 2010
Registry last updated
Mar 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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