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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02634086
Acronym
LOTUS
Enrollment
10000
Registered
2015-12-17
Start date
2004-04-30
Completion date
2018-12-31
Last updated
2015-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Coronary Stenosis, Myocardial Ischemia

Keywords

Coronary artery disease, Percutaneous coronary intervention, Coronary artery bypass graft, Medication therapy

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.

Interventions

None listed

Sponsors

Chinese Academy of Medical Sciences, Fuwai Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
All-cause mortalityThrough study completion, an average of 5 yearThe mortality due to any cause

Secondary

MeasureTime frameDescription
Major adverse cardiac and cerebrovascular eventThrough study completion, an average of 5 yearThe incidence rate of major adverse cardiac and cerebrovascular event (MACCE), which is a combination of all-cause death, myocardial infarction, stroke and repeat revascularization
Myocardial infarctionThrough study completion, an average of 5 yearThe Incidence rate of myocardial infarction, including ST elevation myocardial infarction and non-ST elevation myocardial infarction
StrokeThrough study completion, an average of 5 yearThe incidence rate of stroke, including cerebral infarction and hemorrhage
Repeat revascularizationThrough study completion, an average of 5 yearThe incidence rate of repeat revascularization, including target vessel revascularization and non-target vessel revascularization

Countries

China

Contacts

Primary ContactLei Song, MD
drsongfw@gmail.com+86-13910968125
Backup ContactLei Song, MD
lsongqd@yahoo.com+86-13810532620

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026