Coronary Artery DiseaseNCT05125315
Intraoperative Hemodynamics in CABG
An observational study of Coronary Artery Disease, run by Beijing Anzhen Hospital.
Trial summary
The study is to determine the effects of the intraoperative hemodynamics in patients undergoing coronary artery bypass graft on the short-term and long-term outcomes. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Nov 2021to Dec 2022
- 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: Patients undergoing isolated CABG will included in this study. All the ertracted patients are ethnic Chinese. Patients undergoing emergency surgery or using ECOM/VAD will be excluded.
Who may be able to join
- age18-80 for CABG surgery only
Who cannot join
- Emergency surgery atrial fibrillation using ECMO/VAD
About this study
Official title: Intraoperative Hemodynamics in Patients Undergoing Coronary Artery Bypass Graft for Long-term Outcom
The study is to determine the effects of the intraoperative hemodynamics in patients undergoing coronary artery bypass graft on the short-term and long-term outcomes.
- Conditions
- Coronary Artery Disease
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| low-hemosynamics | Not described | |
| high-hemodynamics | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
long-time motality after CABG
To determine the motality in patients undergoing CABG after 1 year
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study startNov 2021 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe sponsor's other registered studies.
- 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Ma, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05125315
- Sponsor's protocol ID
- 2021-1101
- Status last verified
- Nov 2021
- First submitted
- 8 Nov 2021
- Last updated
- 18 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Hemodynamics in Patients Undergoing Coronary Artery Bypass Graft for Long-term Outcom
- ClinicalTrials.gov ID
- NCT05125315
- Acronym / sponsor ID
- 2021-1101
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- Nov 2021 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 18 Nov 2021 (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.
The study is to determine the effects of the intraoperative hemodynamics in patients undergoing coronary artery bypass graft on the short-term and long-term outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low-hemosynamics | – | – |
| high-hemodynamics | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing isolated CABG will included in this study. All the ertracted patients are ethnic Chinese. Patients undergoing emergency surgery or using ECOM/VAD will be excluded.
Key inclusion criteria (1 listed)
- age18-80 for CABG surgery only
Key exclusion criteria (1 listed)
- Emergency surgery atrial fibrillation using ECMO/VAD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
long-time motality after CABG
Time frame: 1 year
To determine the motality in patients undergoing CABG after 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Beijing Anzhen Hospital.
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 1 inclusion and 1 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 18 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
long-time motality after CABG (time frame: 1 year). 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 18 Nov 2021.