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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04044066
Other study ID # 20172020
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 9, 2017
Est. completion date December 31, 2020

Study information

Verified date July 2020
Source Qilu Hospital of Shandong University
Contact Yuguo Chen, MD,PhD
Phone +8618678812777
Email chen919085@126.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 10000
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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

Study Design


Intervention

Biological:
Plasma biomarker
New emerging plasma biomarkers carrying prognositic information

Locations

Country Name City State
China Qilu Hospital, Shandong University Jinan Shandong

Sponsors (5)

Lead Sponsor Collaborator
Qilu Hospital of Shandong University Central Hospital of Zibo, Chinese PLA General Hospital Hospital, Peking University First Hospital, Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Major Adverse Cardiac Events a composite of cardiac death, myocardial infarction or stroke 12 months
Primary Major bleeding BARC 3 or more bleeding 12 months
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