NCT04107571

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 27, 2019

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

September 27, 2019

Status Verified

September 1, 2019

Enrollment Period

5 years

First QC Date

September 26, 2019

Last Update Submit

September 26, 2019

Conditions

Cardiac Surgery

Keywords

Coronary artery bypass graftBiomarkerPrognosis

Outcome Measures

Primary Outcomes (1)

  • All-cause death and cardiac death

    These data is collected during follow-up visit at in-hospital/1 year after discharge

Secondary Outcomes (1)

  • Major adverse cardiac events (MACE)

    These data is collected during follow-up visit at in-hospital/1 year after discharge

Study Arms (1)

Cohort

Procedure: A type of operation for coranary heart disease patients.

Interventions

A type of operation for coranary heart disease patients.PROCEDURE

A type of operation for coranary heart disease patients.

Cohort

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Anzhen Hospital

Beijing, 100029, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

If a blood specimen is obtained, it will be separated and stored at -80 ℃ as plasma, viable cells, and extracted DNA. If a saliva specimen is obtained, it is stored for DNA. If a tissue specimen is obtained, it will be cut into small pieces and stored at liquid nitrogen.

Study Officials

  • Jie Du, PHD

    Beijing Anzhen Hospital

    STUDY DIRECTOR

Central Study Contacts

Yulin Li, PHD

CONTACT

86-010-64426153lyllyl_1111@163.com

Jie Du, PHD

CONTACT

jiedubj@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2019

First Posted

September 27, 2019

Study Start

January 1, 2019

Primary Completion

January 1, 2024

Study Completion

June 1, 2024

Last Updated

September 27, 2019

Record last verified: 2019-09

Locations

CN(1)