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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Coronary Artery Disease	Procedure: follow-up coronary angiography; Procedure: Clinical follow-up	Phase 4

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	700 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	Randomized Evaluation of Routine Follow-up Coronary Angiography After Percutaneous Coronary Intervention Trial
Actual Study Start Date :	May 2010
Actual Primary Completion Date :	October 2016
Actual Study Completion Date :	October 2016

Arms and Interventions

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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

Outcome Measures

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Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	20 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Contacts and Locations

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Locations

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

Sponsors and Collaborators

Takeshi Morimoto

Investigators

Principal Investigator:	Takeshi Kimura, MD	Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Takeshi Morimoto, Professor, Kyoto University, Graduate School of Medicine
ClinicalTrials.gov Identifier:	NCT01123291 History of Changes
Other Study ID Numbers:	C406
First Posted:	May 14, 2010
Last Update Posted:	March 15, 2017
Last Verified:	March 2017

Keywords provided by Takeshi Morimoto, Kyoto University, Graduate School of Medicine:

follow-up coronary angiography

Additional relevant MeSH terms:

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