Clinical trial NCT02634086: Long-term Outcome of Triple-vessel Coronary Artery Disease Underwent Three Different Strategies (LOTUS)
Official title: Long-term Outcome of Triple-vessel Coronary Artery Disease Underwent Three Different Strategies (LOTUS)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Coronary Stenosis
Myocardial Ischemia
Keywords: Coronary artery disease
Percutaneous coronary intervention
Coronary artery bypass graft
Medication therapy
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2015-12-17
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Between April 2004 and April 2018 in Fuwai Hospital, Beijing, China, consecutive patients with angiography confirmed triple-vessel coronary disease.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: All-cause mortality
timeFrame: Through study completion, an average of 5 year
Secondary outcomes:
measure: Major adverse cardiac and cerebrovascular event
timeFrame: Through study completion, an average of 5 year
measure: Myocardial infarction
timeFrame: Through study completion, an average of 5 year
measure: Stroke
timeFrame: Through study completion, an average of 5 year
measure: Repeat revascularization
timeFrame: Through study completion, an average of 5 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital
state: Beijing
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Lei Song, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.