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Clinical Trials/NCT02634086
NCT02634086
Unknown
Not Applicable

Long-term Outcome of Triple-vessel Coronary Artery Disease Underwent Three Different Strategies (LOTUS)

Chinese Academy of Medical Sciences, Fuwai Hospital1 site in 1 country10,000 target enrollmentApril 2004

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
Enrollment
10000
Locations
1
Primary Endpoint
All-cause mortality
Last Updated
10 years ago

Overview

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).

Detailed Description

About 10,000 participants will be enrolled into this retrospective study. Study coordinators will include both men and women over the age of 18 who had angiographic proved triple-vessel disease in a 15 years long-term. Detailed procedural data will be obtained by the study coordinator and local principal investigator. These data will be entered into the electronic data capture system. Participants will have telephone follow-up interviews conducted by the centralized follow-up center at Fuwai Hospital.

Registry
clinicaltrials.gov
Start Date
April 2004
End Date
December 2018
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
Responsible Party
Principal Investigator
Principal Investigator

Lei Song

MD

Chinese Academy of Medical Sciences, Fuwai Hospital

Eligibility Criteria

Inclusion Criteria

  • Subject has coronary angiography confirmed triple-vessel disease.
  • Subject is ≥ 18 years of age at the time of inclusion.
  • 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).

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

All-cause mortality

Time Frame: Through study completion, an average of 5 year

The mortality due to any cause

Secondary Outcomes

  • Myocardial infarction(Through study completion, an average of 5 year)
  • Major adverse cardiac and cerebrovascular event(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 Sites (1)

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