search
Back to results

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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
follow-up coronary angiography
Clinical follow-up
Sponsored by
Takeshi Morimoto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Artery Disease focused on measuring follow-up coronary angiography

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Sites / Locations

  • Division of Cardiology, Kyoto University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

routine follow-up coronary angiography

clinical follow-up

Arm Description

routine follow-up coronary angiography at 8-12 after discharge for percutaneous coronary intervention

no routine follow-up coronary angiography at 8-12 after discharge for percutaneous coronary intervention

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 13, 2010
Last Updated
March 14, 2017
Sponsor
Takeshi Morimoto
search

1. Study Identification

Unique Protocol Identification Number
NCT01123291
Brief Title
Evaluation of Routine Follow-up Coronary Angiography After Percutaneous Coronary Intervention Trial
Acronym
ReACT
Official Title
Randomized Evaluation of Routine Follow-up Coronary Angiography After Percutaneous Coronary Intervention Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
May 2010 (Actual)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Takeshi Morimoto

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
follow-up coronary angiography

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
700 (Actual)

8. Arms, Groups, and Interventions

Arm Title
routine follow-up coronary angiography
Arm Type
Active Comparator
Arm Description
routine follow-up coronary angiography at 8-12 after discharge for percutaneous coronary intervention
Arm Title
clinical follow-up
Arm Type
Active Comparator
Arm Description
no routine follow-up coronary angiography at 8-12 after discharge for percutaneous coronary intervention
Intervention Type
Procedure
Intervention Name(s)
follow-up coronary angiography
Intervention Description
follow-up coronary angiography at 8-12 months after discharge for percutaneous coronary intervention
Intervention Type
Procedure
Intervention Name(s)
Clinical follow-up
Intervention Description
no routine follow-up coronary angiography at 8-12 months after discharge for percutaneous coronary intervention
Primary Outcome Measure Information:
Title
a composite of death/myocardial infarction/stroke/emergency hospitalization for acute coronary syndrome/hospitalization for congestive heart failure
Description
a composite of death/myocardial infarction/stroke/emergency hospitalization for acute coronary syndrome/hospitalization for congestive heart failure
Time Frame
4.8 years
Secondary Outcome Measure Information:
Title
death
Description
death
Time Frame
4.8 years
Title
cardiac death
Description
cardiac death
Time Frame
4.8 years
Title
myocardial infarction
Description
myocardial infarction
Time Frame
4.8 years
Title
stent thrombosis
Description
stent thrombosis defined bya Academic Reseach Consortium
Time Frame
4.8 years
Title
stroke
Description
both ischemic and hemorrhagic stroke excluding transient ischemic attach
Time Frame
4.8 years
Title
bleeding complications
Description
bleeding complications defined by GUSTO and TIMI
Time Frame
4.8 years
Title
any coronary revascularization
Description
any coronary revascularization
Time Frame
4.8 years
Title
clinically-driven coronary revascularization
Description
clinically-driven coronary revascularization
Time Frame
4.8 years
Title
clinically-driven target-lesion revascularization
Description
clinically-driven target-lesion revascularization
Time Frame
4.8 years
Title
any target-lesion revascularization
Description
any target-lesion revascularization
Time Frame
4.8 years
Title
coronary artery bypass grafting
Description
coronary artery bypass grafting
Time Frame
4.8 years
Title
angina
Description
angina
Time Frame
4.8 years
Title
renal function
Description
estimate-glomerular filtration rate
Time Frame
4.8 years
Title
emergency hospitalization for acute coronary syndrome
Description
emergency hospitalization for acute coronary syndrome
Time Frame
4.8 years
Title
hospitalization for congestive heart failure
Description
hospitalization for congestive heart failure
Time Frame
4.8 years
Title
composite of cardiac death, myocardial infarction or acute coronary syndrome
Description
composite of cardiac death, myocardial infarction or acute coronary syndrome
Time Frame
4.8 years
Title
follow-up coronary angiography
Description
presence of follow-up coronary angiography
Time Frame
4.8 years
Title
clinically-driven follow-up coronary angiography
Description
presence of clinically-driven follow-up coronary angiography
Time Frame
4.8 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients received percutaneous coronary intervention Patients older than 20 years old Patients who will not scheduled any staged percutaneous coronary intervention
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Takeshi Kimura, MD
Organizational Affiliation
Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Cardiology, Kyoto University Hospital
City
Kyoto
ZIP/Postal Code
606-8507
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
28040445
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs