Biomarker-based Prognostic Assessment

NCT ID: NCT04044066

Last Updated: 2020-07-07

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

2017-11-09

Study Completion Date

2020-12-31

Brief Summary

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Coronary artery disease (including stable angina and acute coronary disease) remains the leading mortality and morbidity worldwide. Improvement in biomarker, imaging research have led to new predictors for the prognosis, which may have great clinical value in the current era of personalized medicine. However, there is no available biomarker-based prediction rule for risk assessment of adverse events in patients with stable angina and acute coronary disease. Therefore, we aim to develop and validate a new biomarker-based risk model to improve the prognostication of adverse events (e.g. ischemic and bleeding events ) in the patient population.

Detailed Description

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Patients enrolled in Qilu Hospital of Shandong University (Jinan, China), Chinese PLA General Hospital Hospital (Beijing, China) and Peking University First Hospital (Beijing, China) are designed as the development cohort to derive the risk prediction models of ischemic and bleeding events. Patients enrolled in Peking University Third Hospital ( Beijing, China) Zibo Central hospital (Zibo, China) are designed as the independent validation cohort.

Conditions

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Acute Coronary Syndrome Stable Angina

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Plasma biomarker

New emerging plasma biomarkers carrying prognositic information

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. Hospitalized patients with the diagnosis of any type of coronary artery disease (stable angina, unstable angina, non ST-segment elevation myocardial infarction or ST-segment elevation myocardial infarction)
2. Age ≥18 years of age and \<85 years of age
3. Patient or guardian provided informed written consent

Exclusion Criteria

1. Prior surgery (cardiac or non-cardiac), trauma or clinically evident coagulopathic bleeding (e.g. gastrointestinal, genitourinary, et al)
2. Patient with non-cardiac co-morbidities with life expectancy less than 12 months
3. Patients unwilling or unable to comply with all clinical follow-up schedules at 30 days, 6 months and 12 months after discharge
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role collaborator

Chinese PLA General Hospital Hospital

UNKNOWN

Sponsor Role collaborator

Peking University First Hospital

OTHER

Sponsor Role collaborator

Central Hospital of Zibo

OTHER

Sponsor Role collaborator

Qilu Hospital of Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Qilu Hospital, Shandong University

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yuguo Chen, MD,PhD

Role: CONTACT

+8618678812777

Facility Contacts

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Yuguo Chen, MD,PhD

Role: primary

+8618678812777

References

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Wang J, Zhang T, Xu F, Gao W, Chen M, Zhu H, Xu J, Yin X, Pang J, Zhang S, Wei M, Chen J, Liu Y, Yu X, Chew DP, Chen Y. GDF-15 at admission predicts cardiovascular death, heart failure, and bleeding outcomes in patients with CAD. ESC Heart Fail. 2023 Oct;10(5):3123-3132. doi: 10.1002/ehf2.14484. Epub 2023 Aug 24.

Reference Type DERIVED
PMID: 37620152 (View on PubMed)

Other Identifiers

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20172020

Identifier Type: -

Identifier Source: org_study_id

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