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

Phase 4

Completed

• Conditions: Coronary Artery Disease
• Interventions: Procedure: Clinical follow-up; Procedure: follow-up coronary angiography

• Registration Number: NCT01123291
• Lead Sponsor: Takeshi Morimoto

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.

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 Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-13
• Study First Submitted QC: 2010-05-13
• Study First Posted: 2010-05-14
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-14
• Last Update Posted: 2017-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
clinical follow-up	Clinical follow-up	no routine follow-up coronary angiography at 8-12 after discharge for percutaneous coronary intervention
routine follow-up coronary angiography	follow-up coronary angiography	routine follow-up coronary angiography at 8-12 after discharge for percutaneous coronary intervention

Primary Outcome Measures

Name	Time	Method
a composite of death/myocardial infarction/stroke/emergency hospitalization for acute coronary syndrome/hospitalization for congestive heart failure	4.8 years	a composite of death/myocardial infarction/stroke/emergency hospitalization for acute coronary syndrome/hospitalization for congestive heart failure

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Division of Cardiology, Kyoto University Hospital; 🇯🇵 Kyoto, Japan