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NCT01123291 Clinical Trial

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

Coronary Artery Disease Clinical Trial

— ReACT  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01123291
Other study ID # C406
Secondary ID
Status Completed
Phase Phase 4
First received May 13, 2010
Last updated March 14, 2017
Start date May 2010
Est. completion date October 2016

Study information
Verified date March 2017
Source Kyoto University, Graduate School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 700
Est. completion date October 2016
Est. primary completion date October 2016
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria:

- Patients received percutaneous coronary intervention

- Patients older than 20 years old

- Patients who will not scheduled any staged percutaneous coronary intervention

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Japan Division of Cardiology, Kyoto University Hospital Kyoto

Sponsors (1)
Lead Sponsor Collaborator
Takeshi Morimoto

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary a composite of death/myocardial infarction/stroke/emergency hospitalization for acute coronary syndrome/hospitalization for congestive heart failure a composite of death/myocardial infarction/stroke/emergency hospitalization for acute coronary syndrome/hospitalization for congestive heart failure 4.8 years
Secondary death death 4.8 years
Secondary cardiac death cardiac death 4.8 years
Secondary myocardial infarction myocardial infarction 4.8 years
Secondary stent thrombosis stent thrombosis defined bya Academic Reseach Consortium 4.8 years
Secondary stroke both ischemic and hemorrhagic stroke excluding transient ischemic attach 4.8 years
Secondary bleeding complications bleeding complications defined by GUSTO and TIMI 4.8 years
Secondary any coronary revascularization any coronary revascularization 4.8 years
Secondary clinically-driven coronary revascularization clinically-driven coronary revascularization 4.8 years
Secondary clinically-driven target-lesion revascularization clinically-driven target-lesion revascularization 4.8 years
Secondary any target-lesion revascularization any target-lesion revascularization 4.8 years
Secondary coronary artery bypass grafting coronary artery bypass grafting 4.8 years
Secondary angina angina 4.8 years
Secondary renal function estimate-glomerular filtration rate 4.8 years
Secondary emergency hospitalization for acute coronary syndrome emergency hospitalization for acute coronary syndrome 4.8 years
Secondary hospitalization for congestive heart failure hospitalization for congestive heart failure 4.8 years
Secondary composite of cardiac death, myocardial infarction or acute coronary syndrome composite of cardiac death, myocardial infarction or acute coronary syndrome 4.8 years
Secondary follow-up coronary angiography presence of follow-up coronary angiography 4.8 years
Secondary clinically-driven follow-up coronary angiography presence of clinically-driven follow-up coronary angiography 4.8 years
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