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

Randomized 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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Procedure: follow-up coronary angiography; Procedure: Clinical follow-up

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
• Enrollment (Actual): 700
• Phase: Phase 4

Contacts and Locations

Study Locations

• Japan
  • Kyoto, Japan, 606-8507
    • Division of Cardiology, Kyoto University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Takeshi Morimoto
• Investigators: Principal Investigator: Takeshi Kimura, MD, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine

Publications and helpful links

General Publications

• Shiomi H, Morimoto T, Kitaguchi S, Nakagawa Y, Ishii K, Haruna Y, Takamisawa I, Motooka M, Nakao K, Matsuda S, Mimoto S, Aoyama Y, Takeda T, Murata K, Akao M, Inada T, Eizawa H, Hyakuna E, Awano K, Shirotani M, Furukawa Y, Kadota K, Miyauchi K, Tanaka M, Noguchi Y, Nakamura S, Yasuda S, Miyazaki S, Daida H, Kimura K, Ikari Y, Hirayama H, Sumiyoshi T, Kimura T; ReACT Investigators. The ReACT Trial: Randomized Evaluation of Routine Follow-up Coronary Angiography After Percutaneous Coronary Intervention Trial. JACC Cardiovasc Interv. 2017 Jan 23;10(2):109-117. doi: 10.1016/j.jcin.2016.10.018. Epub 2016 Dec 28.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2010
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: May 13, 2010
• First Submitted That Met QC Criteria: May 13, 2010
• First Posted (Estimate): May 14, 2010

Study Record Updates

• Last Update Posted (Actual): March 15, 2017
• Last Update Submitted That Met QC Criteria: March 14, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: follow-up coronary angiography
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: C406

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No