Cardiac SurgeryASBA-CABGNCT04107571
A Registry Study on Serumal Biomarkers About Adverse Events in Patients Undergoing Coronary Artery Bypass Grafting.
An observational study of Cardiac Surgery, run by Beijing Institute of Heart, Lung and Blood Vessel Diseases at 1 site in China.
Trial summary
This is a national registry study to determine the serumal biomarkers for prognosis of adverse events in patients undergoing coronary artery bypass grafting. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- A type of operation for coranary heart disease patients.
- Type of treatment
- Surgery or procedure
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Group consists of patients who underwent coronary artery bypass grafting in Beijing Anzhen Hospital.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Jie Du, PHD contact
China1 site, 1 recruiting
- Recruiting
Beijing Anzhen Hospital
Beijing, 100029
ke-xu Yang, 86-010-64426153, EC@anzhenGCP.com
About this study
Official title: 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.
- Conditions
- Cardiac Surgery
- Being tested
- A type of operation for coranary heart disease patients.
- Keywords
- Coronary artery bypass graft, Biomarker, Prognosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A type of operation for coranary heart disease patients.Procedure or surgery
A type of operation for coranary heart disease patients.
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Not described Receives: Procedure: A type of operation for coranary heart disease patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause death and cardiac death
Measured: These data is collected during follow-up visit at in-hospital/1 year after discharge
Secondary outcomes (1)
Major adverse cardiac events (MACE)
A composite of death, myocardial infarction, stroke, heart failure, ventricular arrhythmia
Measured: These data is collected during follow-up visit at in-hospital/1 year after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start1 Jan 2019
- Primary completionJan 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Institute of Heart, Lung and Blood Vessel Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jie Du, PHD, Study director, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04107571
- Sponsor's protocol ID
- 20190924
- Acronym
- ASBA-CABG
- Status last verified
- Sep 2019
- First submitted
- 26 Sep 2019
- Last updated
- 27 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Chinese Registry to Determine the Serumal Biomarkers for Prognosis of Adverse Events in Patients Undergoing Coronary Artery Bypass Grafting.
- ClinicalTrials.gov ID
- NCT04107571
- Acronym / sponsor ID
- ASBA-CABG / 20190924
- Conditions
- Cardiac Surgery
- Keywords
- Coronary artery bypass graft, Biomarker, Prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Beijing Institute of Heart, Lung and Blood Vessel DiseasesUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 27 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a national registry study to determine the serumal biomarkers for prognosis of adverse events in patients undergoing coronary artery bypass grafting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | Procedure: A type of operation for coranary heart disease patients. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Group consists of patients who underwent coronary artery bypass grafting in Beijing Anzhen Hospital.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A type of operation for coranary heart disease patients.A type of operation for coranary heart disease patients. | Procedure or surgery | Cohort |
Primary outcome
All-cause death and cardiac death
Time frame: These data is collected during follow-up visit at in-hospital/1 year after discharge
1 secondary outcome
Major adverse cardiac events (MACE)
Time frame: These data is collected during follow-up visit at in-hospital/1 year after discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2019.
Related trials for Cardiac Surgery
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
Recruiting
Change in Platelet Lipid Metabolism and Procoagulant Phenotype Induced by Cardiopulmonary Bypass. Impact on Postoperative Inflammatory Response and Bleeding Complications During Cardiac Surgery.
Cardiac Surgery, Cardiopulmonary Bypass
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jie Du, PHD contact
Jie Du, PHD study director
Beijing Anzhen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Surgery, run by Beijing Institute of Heart, Lung and Blood Vessel Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yulin Li, PHD (86-010-64426153, lyllyl_1111@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause death and cardiac death (time frame: These data is collected during follow-up visit at in-hospital/1 year after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2019.