Evaluation of Routine Follow-up Coronary Angiography After Percutaneous Coronary Intervention Trial (ReACT)
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| ClinicalTrials.gov Identifier: NCT01123291 |
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Recruitment Status :
Completed
First Posted : May 14, 2010
Last Update Posted : March 15, 2017
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Sponsor:
Takeshi Morimoto
Information provided by (Responsible Party):
Takeshi Morimoto, Kyoto University, Graduate School of Medicine
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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 |
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 (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 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Heart Attack
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: routine follow-up coronary angiography
routine follow-up coronary angiography at 8-12 after discharge for percutaneous coronary intervention
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Procedure: follow-up coronary angiography
follow-up coronary angiography at 8-12 months after discharge for percutaneous coronary intervention |
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Active Comparator: clinical follow-up
no routine follow-up coronary angiography at 8-12 after discharge for percutaneous coronary intervention
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Procedure: Clinical follow-up
no routine follow-up coronary angiography at 8-12 months after discharge for percutaneous coronary intervention |
Primary Outcome Measures :
- 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 :
- death [ Time Frame: 4.8 years ]death
- cardiac death [ Time Frame: 4.8 years ]cardiac death
- myocardial infarction [ Time Frame: 4.8 years ]myocardial infarction
- stent thrombosis [ Time Frame: 4.8 years ]stent thrombosis defined bya Academic Reseach Consortium
- stroke [ Time Frame: 4.8 years ]both ischemic and hemorrhagic stroke excluding transient ischemic attach
- bleeding complications [ Time Frame: 4.8 years ]bleeding complications defined by GUSTO and TIMI
- any coronary revascularization [ Time Frame: 4.8 years ]any coronary revascularization
- clinically-driven coronary revascularization [ Time Frame: 4.8 years ]clinically-driven coronary revascularization
- clinically-driven target-lesion revascularization [ Time Frame: 4.8 years ]clinically-driven target-lesion revascularization
- any target-lesion revascularization [ Time Frame: 4.8 years ]any target-lesion revascularization
- coronary artery bypass grafting [ Time Frame: 4.8 years ]coronary artery bypass grafting
- angina [ Time Frame: 4.8 years ]angina
- renal function [ Time Frame: 4.8 years ]estimate-glomerular filtration rate
- emergency hospitalization for acute coronary syndrome [ Time Frame: 4.8 years ]emergency hospitalization for acute coronary syndrome
- hospitalization for congestive heart failure [ Time Frame: 4.8 years ]hospitalization for congestive heart failure
- 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
- follow-up coronary angiography [ Time Frame: 4.8 years ]presence of follow-up coronary angiography
- clinically-driven follow-up coronary angiography [ Time Frame: 4.8 years ]presence of clinically-driven follow-up coronary angiography
Information from the National Library of Medicine
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| Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01123291
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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 Key Record Dates |
| Last Update Posted: | March 15, 2017 |
| Last Verified: | March 2017 |
Keywords provided by Takeshi Morimoto, Kyoto University, Graduate School of Medicine:
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follow-up coronary angiography |
Additional relevant MeSH terms:
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Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |