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

NCT ID: NCT02634086

Last Updated: 2015-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-04-30

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease Coronary Stenosis Myocardial Ischemia

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Percutaneous coronary intervention

Patients with triple-vessel coronary artery disease underwent percutaneous coronary intervention.

No interventions assigned to this group

Coronary artery bypass graft

Patients with triple-vessel coronary artery disease underwent coronary artery bypass graft.

No interventions assigned to this group

Optimal medication therapy

Patients with triple-vessel coronary artery disease underwent optimal medication therapy only.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Lei Song

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lei Song, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Medical Sciences, Fuwai Hospital

Locations

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Fuwai Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lei Song, MD

Role: CONTACT

Phone: +86-13910968125

Email: [email protected]

Lei Song, MD

Role: CONTACT

Phone: +86-13810532620

Email: [email protected]

Facility Contacts

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Lei Song, MD

Role: primary

Lei Song, MD

Role: backup

References

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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.

Reference Type DERIVED
PMID: 29271373 (View on PubMed)

Other Identifiers

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2010CB732601

Identifier Type: -

Identifier Source: org_study_id