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

Coronary Artery Disease Clinical Trial

— LOTUS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02634086
• Other study ID #: 2010CB732601
• Status: Recruiting
• Phase: N/A
• First received: December 14, 2015
• Last updated: December 17, 2015
• Start date: April 2004
• Est. completion date: December 2018

Study information

• Verified date: December 2015
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: Lei Song, MD
• Phone: +86-13910968125
• Email: drsongfw[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 2018
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Stenosis
• Myocardial Ischemia

Locations

Country	Name	City	State
China	Fuwai Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality	The mortality due to any cause	Through study completion, an average of 5 year	No
Secondary	Major adverse cardiac and cerebrovascular event	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	Through study completion, an average of 5 year	No
Secondary	Myocardial infarction	The Incidence rate of myocardial infarction, including ST elevation myocardial infarction and non-ST elevation myocardial infarction	Through study completion, an average of 5 year	No
Secondary	Stroke	The incidence rate of stroke, including cerebral infarction and hemorrhage	Through study completion, an average of 5 year	No
Secondary	Repeat revascularization	The incidence rate of repeat revascularization, including target vessel revascularization and non-target vessel revascularization	Through study completion, an average of 5 year	No