A Registry Study on Serumal Biomarkers About Adverse Events in Patients Undergoing Coronary Artery Bypass Grafting. (ASBA-CABG)

September 26, 2019 updated by: Beijing Institute of Heart, Lung and Blood Vessel Diseases

A Chinese Registry to Determine the Serumal Biomarkers for Prognosis of Adverse Events in Patients Undergoing Coronary Artery Bypass Grafting.

This is a national registry study to determine the serumal biomarkers for prognosis of adverse events in patients undergoing coronary artery bypass grafting.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100029
        • Recruiting
        • Beijing Anzhen Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Group consists of patients who underwent coronary artery bypass grafting in Beijing Anzhen Hospital.

Description

Inclusion Criteria:

  1. Subject undergoing coronary artery bypass grafting;
  2. Age is more than 18 and less than 80 years old;
  3. Male and non pregnancy female;
  4. Subject who understands study requirements and agrees to sign an informed consent from prior to study procedures.

Exclusion Criteria:

  1. Pregnancy female;
  2. Participate in other clinical trial in the last 1 month.
  3. Subject who doesn't agree to sign an informed consent from prior to study procedures.
  4. Subject undergoing repeat CABG, concomitant valve or other cardiac surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort
Procedure: A type of operation for coranary heart disease patients.
A type of operation for coranary heart disease patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All-cause death and cardiac death
Time Frame: These data is collected during follow-up visit at in-hospital/1 year after discharge
These data is collected during follow-up visit at in-hospital/1 year after discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major adverse cardiac events (MACE)
Time Frame: These data is collected during follow-up visit at in-hospital/1 year after discharge
A composite of death, myocardial infarction, stroke, heart failure, ventricular arrhythmia
These data is collected during follow-up visit at in-hospital/1 year after discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Institute of Heart, Lung and Blood Vessel Diseases

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Anticipated)

January 1, 2024

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

September 26, 2019

First Submitted That Met QC Criteria

September 26, 2019

First Posted (Actual)

September 27, 2019

Study Record Updates

Last Update Posted (Actual)

September 27, 2019

Last Update Submitted That Met QC Criteria

September 26, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 20190924

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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