Biomarker-based Prognostic Assessment

NCT04044066 | Unknown DMC

• 1 other identifier: 20172020
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Coronary Syndrome; Stable Angina

Outcome Measures

Primary Outcomes (2)

• Major Adverse Cardiac Events

  a composite of cardiac death, myocardial infarction or stroke

  12 months

• Major bleeding

  BARC 3 or more bleeding

  12 months

Interventions

Plasma biomarker BIOLOGICAL

New emerging plasma biomarkers carrying prognositic information

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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 6 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.

You may qualify if:

• 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)
• Age ≥18 years of age and \<85 years of age
• Patient or guardian provided informed written consent

You may not qualify if:

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

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead
• Peking University Third Hospital: collaborator
• Chinese PLA General Hospital Hospital: collaborator
• Peking University First Hospital: collaborator
• Central Hospital of Zibo: collaborator

Study Sites (1)

Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 37620152 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

plasma, whole blood, DNA

MeSH Terms

Conditions

Acute Coronary Syndrome; Angina, Stable

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yuguo Chen, MD,PhD

CONTACT

+8618678812777; chen919085@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2019
• First Posted: August 2, 2019
• Study Start: November 9, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: July 7, 2020

Record last verified: 2020-07

Locations

CN (1)