NCT01123291

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 700 (actual)
• Sponsor: Takeshi Morimoto · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
PROCEDURE	follow-up coronary angiography	follow-up coronary angiography at 8-12 months 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

Timeline

• Start date: 2010-05-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2010-05-14
• Last updated: 2017-03-15

Locations

1 site across 1 country: Japan