NCT02634086

Brief Summary

The study is to determine the long-term outcome of patients with coronary triple vessels disease (TVD) in the real world of China, by three different treatment strategies: percutaneous coronary intervention (PCI), Coronary artery bypass graft (CABG) or optimal medication therapy (OMT).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

April 1, 2004

Completed
11.7 years until next milestone

First Submitted

Initial submission to the registry

December 14, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 17, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

December 18, 2015

Status Verified

December 1, 2015

Enrollment Period

12 years

First QC Date

December 14, 2015

Last Update Submit

December 17, 2015

Conditions

Coronary Artery DiseaseCoronary StenosisMyocardial Ischemia

Keywords

Coronary artery diseasePercutaneous coronary interventionCoronary artery bypass graftMedication therapy

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality

    The mortality due to any cause

    Through study completion, an average of 5 year

Secondary Outcomes (4)

  • Major adverse cardiac and cerebrovascular event

    Through study completion, an average of 5 year

  • Myocardial infarction

    Through study completion, an average of 5 year

  • Stroke

    Through study completion, an average of 5 year

  • Repeat revascularization

    Through study completion, an average of 5 year

Study Arms (3)

Percutaneous coronary intervention

Patients with triple-vessel coronary artery disease underwent percutaneous coronary intervention.

Coronary artery bypass graft

Patients with triple-vessel coronary artery disease underwent coronary artery bypass graft.

Optimal medication therapy

Patients with triple-vessel coronary artery disease underwent optimal medication therapy only.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Between April 2004 and April 2018 in Fuwai Hospital, Beijing, China, consecutive patients with angiography confirmed triple-vessel coronary disease.

You may qualify if:

  • Subject has coronary angiography confirmed triple-vessel disease.
  • Subject is willing to comply with all protocol-required follow-up evaluation (patient will be followed during 1 month after hospital to assess any complications and clinical status).

You may not qualify if:

  • Subject is participating in another investigational clinical trial that may cause non-compliance with the protocol or confound data interpretation.
  • Female subjects with a positive quantitative or qualitative pregnancy test, in accordance with hospital policy.
  • Subjects with no way contact by telephone for follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuwai Hospital

Beijing, Beijing Municipality, 100037, China

RECRUITING

Related Publications (1)

  • Xu JJ, Zhang Y, Jiang L, Tian J, Song L, Gao Z, Feng XX, Zhao XY, Zhao YY, Wang D, Sun K, Xu LJ, Liu R, Gao RL, Xu B, Song L, Yuan JQ. Comparison of Long-term Outcomes in Patients with Premature Triple-vessel Coronary Disease Undergoing Three Different Treatment Strategies: A Prospective Cohort Study. Chin Med J (Engl). 2018 Jan 5;131(1):1-9. doi: 10.4103/0366-6999.221273.

    PMID: 29271373DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseCoronary StenosisMyocardial Ischemia

Condition Hierarchy (Ancestors)

Coronary DiseaseHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Lei Song, MD

    Chinese Academy of Medical Sciences, Fuwai Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Song, MD

CONTACT

+86-13910968125drsongfw@gmail.com

Lei Song, MD

CONTACT

+86-13810532620lsongqd@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 14, 2015

First Posted

December 17, 2015

Study Start

April 1, 2004

Primary Completion

April 1, 2016

Study Completion

December 1, 2018

Last Updated

December 18, 2015

Record last verified: 2015-12

Locations

CN(1)