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

• Conditions: Myocardial Ischemia; Coronary Artery Disease; Coronary Stenosis

• Registration Number: NCT02634086
• Lead Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

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.

Study Timeline

• Study Start: 2004-04
• Status Verified: 2015-12
• Study First Submitted: 2015-12-14
• Study First Submitted QC: 2015-12-15
• Study First Posted: 2015-12-17
• Last Update Submitted: 2015-12-17
• Last Update Posted: 2015-12-18
• Primary Completion: 2016-04
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

1. Subject has coronary angiography confirmed triple-vessel disease.
2. Subject is ≥ 18 years of age at the time of inclusion.
3. 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

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All-cause mortality	Through study completion, an average of 5 year	The mortality due to any cause

Secondary Outcome Measures

Name	Time	Method
Myocardial infarction	Through study completion, an average of 5 year	The Incidence rate of myocardial infarction, including ST elevation myocardial infarction and non-ST elevation myocardial infarction
Major adverse cardiac and cerebrovascular event	Through study completion, an average of 5 year	The incidence rate of major adverse cardiac and cerebrovascular event (MACCE), which is a combination of all-cause death, myocardial infarction, stroke and repeat revascularization
Stroke	Through study completion, an average of 5 year	The incidence rate of stroke, including cerebral infarction and hemorrhage
Repeat revascularization	Through study completion, an average of 5 year	The incidence rate of repeat revascularization, including target vessel revascularization and non-target vessel revascularization

Trial Locations

Locations (1)

Fuwai Hospital; 🇨🇳 Beijing, Beijing, China