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Biomarker-based Prognostic Assessment

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ClinicalTrials.gov Identifier: NCT04044066
Recruitment Status : Recruiting
First Posted : August 2, 2019
Last Update Posted : August 2, 2019
Sponsor:
Collaborators:
Peking University Third Hospital
Chinese PLA General Hospital Hospital
West China Hospital
Peking University First Hospital
Central South University
Information provided by (Responsible Party):
Qilu Hospital of Shandong University

Brief Summary:
Coronary artery disease (including stable angina and acute coronary disease) remains the leading mortality and morbidity worldwide. Improvements 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 multimarker-based score for assessment of the risk of adverse events in patients with stable angina and acute coronary disease. Therefore, we aim to develop and validate a new biomarker-based risk score to improve the prognostication of adverse events (e.g. ischemic and bleeding events ) in the patient population.

Condition or disease Intervention/treatment
Acute Coronary Syndrome Stable Angina Biological: Plasma biomarker

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: BIomarker-based Prognostic Assessment for Patients With Stable Angina and Acute Coronary Syndromes (BIPass)
Actual Study Start Date : November 9, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina


Intervention Details:
  • Biological: Plasma biomarker
    New emerging plasma biomarkers carrying prognositic information


Primary Outcome Measures :
  1. Major Adverse Cardiac Events [ Time Frame: 12 months ]
    a composite of cardiac death, myocardial infarction or stroke

  2. Major bleeding [ Time Frame: 12 months ]
    BARC 3 or more bleeding


Biospecimen Retention:   Samples With DNA
plasma, whole blood, DNA


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
In this prospective, multicenter registry study, we will consecutively enroll eligible patients according to the pre-specified inclusion and exclusion criteria in 5 tertiary hospitals in China. Patients meeting all eligibility criteria will be tracked and their hospitalization data will be collected including baseline clinical and demographic data, risk factors, blood drawn and storage, lab testing results, angiographic and procedural data (if appropriate), medication and adverse events. Clinical follow-up visits will be sheduled at 30 days, 6 months and 12 months after discharge by telephone contact. Follow-up data will be collected and assessment for death (cardiac, non-cardiac), myocardial infarction, stroke, revascularization or bleeding events will be conducted.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04044066


Contacts
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Contact: Yuguo Chen, MD,PhD +8618678812777 chen919085@126.com

Locations
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China, Shandong
Qilu Hospital, Shandong University Recruiting
Jinan, Shandong, China, 250012
Contact: Yuguo Chen, MD,PhD    +8618678812777    chen919085@126.com   
Sponsors and Collaborators
Qilu Hospital of Shandong University
Peking University Third Hospital
Chinese PLA General Hospital Hospital
West China Hospital
Peking University First Hospital
Central South University

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Responsible Party: Qilu Hospital of Shandong University
ClinicalTrials.gov Identifier: NCT04044066     History of Changes
Other Study ID Numbers: 20172020
First Posted: August 2, 2019    Key Record Dates
Last Update Posted: August 2, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chest Pain
Pain
Acute Coronary Syndrome
Angina, Stable
Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Angina Pectoris
Neurologic Manifestations
Signs and Symptoms