Evaluation of Routine Follow-up Coronary Angiography After Percutaneous Coronary Intervention Trial (ReACT)
This study is currently recruiting participants.
(see Contacts and Locations)
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01123291
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 Coronary Disease Myocardial Ischemia Arterial Occlusive Diseases |
Arteriosclerosis Cardiovascular Diseases Heart Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on March 01, 2015