Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)NCT07054502
Prospective Validation of DL Model for Postoperative MACCE Prediction
An observational study of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE), run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study aims to prospectively validate a deep learning model developed using retrospective data to predict major adverse cardiac and cerebrovascular events (MACCE) occurring within 30 days after non-cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
- How many people
- 7,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Jul 2025to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Non-cardiac surgical patients
Who may be able to join
- Adults aged 18 or older undergoing non-cardiac surgery under general or regional anesthesia at Seoul National University Hospital
Who cannot join
- Reoperation within 30 days after initial surgery
- Organ procurement or pregnancy-related procedures
- Ambulatory-based surgery
- Preoperative tracheal intubation before entering the operating room
- Surgeries performed outside the operating room
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Seoul National University Hospital
Seoul, 03080
Hyun-Kyu Yoon, 82-2-2072-2469, hyunkyu18@gmail.com
About this study
Official title: Prospective Validation of Deep Learning Model to Predict Postoperative Major Adverse Cardiac and Cerebrovascular Event
This study aims to prospectively validate a deep learning model developed using retrospective data to predict major adverse cardiac and cerebrovascular events (MACCE) occurring within 30 days after non-cardiac surgery. The validation will be performed using prospectively collected data from patients undergoing non-cardiac surgery under general or regional anesthesia.
- Keywords
- Deep learning, Non-cardiac surgery, Electrocardiogram, Multimodal, MACCE
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 |
|---|---|---|
| Non-cardiac surgical patients | Patient undergoing non-cardiac surgery under regional or general anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular and cerebrovascular events (MACCE)
Occurrence of MACCE within 30 days after surgery (composite outcome including myocardial infarction, stroke, coronary revascularization, heart failure, and death)
Measured: within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start10 Jul 2025 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)Studies of the same condition, open and under way.
- More trials run by Seoul National University 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
- 7,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyun-Kyu Yoon, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07054502
- Sponsor's protocol ID
- 2503-210-1630
- Status last verified
- Jun 2025
- First submitted
- 27 Jun 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Validation of Deep Learning Model to Predict Postoperative Major Adverse Cardiac and Cerebrovascular Event
- ClinicalTrials.gov ID
- NCT07054502
- Acronym / sponsor ID
- 2503-210-1630
- Keywords
- Deep learning, Non-cardiac surgery, Electrocardiogram, Multimodal, MACCE
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 7,000 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 10 Jul 2025 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 Jul 2025 (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 study aims to prospectively validate a deep learning model developed using retrospective data to predict major adverse cardiac and cerebrovascular events (MACCE) occurring within 30 days after non-cardiac surgery. The validation will be performed using prospectively collected data from patients undergoing non-cardiac surgery under general or regional anesthesia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-cardiac surgical patients | – | –Patient undergoing non-cardiac surgery under regional or general anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Non-cardiac surgical patients
Key inclusion criteria (1 listed)
- Adults aged 18 or older undergoing non-cardiac surgery under general or regional anesthesia at Seoul National University Hospital
Key exclusion criteria (5 listed)
- Reoperation within 30 days after initial surgery
- Organ procurement or pregnancy-related procedures
- Ambulatory-based surgery
- Preoperative tracheal intubation before entering the operating room
- Surgeries performed outside the operating room
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
Major adverse cardiovascular and cerebrovascular events (MACCE)
Time frame: within 30 days after surgery
Occurrence of MACCE within 30 days after surgery (composite outcome including myocardial infarction, stroke, coronary revascularization, heart failure, and death)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Individual participant dataSharing planned: No
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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.
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 Major Adverse Cardiovascular and Cerebrovascular Events (MACCE), run by Seoul National University Hospital at 1 site in South Korea.
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 5 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: opening soon, as of the sponsor's last update on 8 Jul 2025. 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 South Korea. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hyun-Kyu Yoon, MD (82-2-2072-1146, hyunkyu18@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiovascular and cerebrovascular events (MACCE) (time frame: within 30 days after surgery). 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 8 Jul 2025.