Evaluation of Routine Follow-up Coronary Angiography After Percutaneous Coronary Intervention Trial (ReACT)
This study is currently recruiting participants.
Verified August 2012 by Kyoto University, Graduate School of Medicine
Sponsor:
Takeshi Morimoto
Information provided by (Responsible Party):
Takeshi Morimoto, Kyoto University, Graduate School of Medicine
ClinicalTrials.gov Identifier:
NCT01123291
First received: May 13, 2010
Last updated: August 1, 2012
Last verified: August 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Coronary Artery Disease |
Procedure: follow-up coronary angiography Procedure: Clinical follow-up |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Randomized Evaluation of Routine Follow-up Coronary Angiography After Percutaneous Coronary Intervention Trial |
Resource links provided by NLM:
Further study details as provided by Kyoto University, Graduate School of Medicine:
Primary Outcome Measures:
- a composite of death/myocardial infarction/stroke/emergency hospitalization for acute coronary syndrome/hospitalization for congestive heart failure [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]a composite of death/myocardial infarction/stroke/emergency hospitalization for acute coronary syndrome/hospitalization for congestive heart failure
Secondary Outcome Measures:
- death [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]death
- cardiac death [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]cardiac death
- myocardial infarction [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]myocardial infarction
- stent thrombosis [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]stent thrombosis defined bya Academic Reseach Consortium
- stroke [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]both ischemic and hemorrhagic stroke excluding transient ischemic attach
- bleeding complications [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]bleeding complications defined by GUSTO and TIMI
- any coronary revascularization [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]any coronary revascularization
- clinically-driven coronary revascularization [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]clinically-driven coronary revascularization
- clinically-driven target-lesion revascularization [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]clinically-driven target-lesion revascularization
- any target-lesion revascularization [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]any target-lesion revascularization
- coronary artery bypass grafting [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]coronary artery bypass grafting
- angina [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]angina
- renal function [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]estimate-glomerular filtration rate
- emergency hospitalization for acute coronary syndrome [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]emergency hospitalization for acute coronary syndrome
- hospitalization for congestive heart failure [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]hospitalization for congestive heart failure
- composite of cardiac death, myocardial infarction or acute coronary syndrome [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]composite of cardiac death, myocardial infarction or acute coronary syndrome
- follow-up coronary angiography [ Time Frame: 3 years ] [ Designated as safety issue: No ]presence of follow-up coronary angiography
- clinically-driven follow-up coronary angiography [ Time Frame: 3 years ] [ Designated as safety issue: No ]presence of clinically-driven follow-up coronary angiography
| Estimated Enrollment: | 3300 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01123291
Contacts
| Contact: Takeshi Kimura, MD | +81-75-751-4254 | taketaka@kuhp.kyoto-u.ac.jp |
| Contact: Takeshi Morimoto, MD | +81-75-751-4890 | office@kuhp.kyoto-u.ac.jp |
Locations
| Japan | |
| Division of Cardiology, Kyoto University Hospital | Recruiting |
| Kyoto, Japan, 606-8507 | |
| Contact: Takeshi Kimura, MD +81-75-751-4254 taketaka@kuhp.kyoto-u.ac.jp | |
| Contact: Hiroki Shiomi, MD +81-75-751-4255 hishiomi@kuhp.kyoto-u.ac.jp | |
| Principal Investigator: Takeshi Kimura, MD | |
Sponsors and Collaborators
Takeshi Morimoto
Investigators
| Principal Investigator: | Takeshi Kimura, MD | Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine |
More Information
No publications provided
| Responsible Party: | Takeshi Morimoto, Professor, Kyoto University, Graduate School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01123291 History of Changes |
| Other Study ID Numbers: | C406 |
| Study First Received: | May 13, 2010 |
| Last Updated: | August 1, 2012 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by 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 |
ClinicalTrials.gov processed this record on May 21, 2013