NCT01123291

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for phase_4 coronary-artery-disease

Timeline
Completed

Started May 2010

Longer than P75 for phase_4 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

May 13, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 14, 2010

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

March 15, 2017

Status Verified

March 1, 2017

Enrollment Period

6.4 years

First QC Date

May 13, 2010

Last Update Submit

March 14, 2017

Conditions

Coronary Artery Disease

Keywords

follow-up coronary angiography

Outcome Measures

Primary Outcomes (1)

  • 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

    4.8 years

Secondary Outcomes (18)

  • death

    4.8 years

  • cardiac death

    4.8 years

  • myocardial infarction

    4.8 years

  • stent thrombosis

    4.8 years

  • stroke

    4.8 years

  • +13 more secondary outcomes

Study Arms (2)

routine follow-up coronary angiography

ACTIVE COMPARATOR

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

Procedure: follow-up coronary angiography

clinical follow-up

ACTIVE COMPARATOR

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

Procedure: Clinical follow-up

Interventions

follow-up coronary angiographyPROCEDURE

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

routine follow-up coronary angiography
Clinical follow-upPROCEDURE

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

clinical follow-up

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Cardiology, Kyoto University Hospital

Kyoto, Kyoto, 606-8507, Japan

Location

Related Publications (1)

  • 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.

    PMID: 28040445DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Takeshi Kimura, MD

    Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 13, 2010

First Posted

May 14, 2010

Study Start

May 1, 2010

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

March 15, 2017

Record last verified: 2017-03

Locations

JP(1)