Myocardial InfarctionNCT06767943
Predicting Myocardial Infarction After Abdominal Surgery: Clinical Scores & Biomarkers
An observational study of Myocardial Infarction, run by Benha University at 1 site in Egypt.
Trial summary
All patients undergoing non-cardiac surgery who met the inclusion criteria underwent a preoperative evaluation using specific assessment tools. Following surgery, patients were closely monitored in the intermediate care unit for the first 24 hours for the development of acute myocardial infarction (AMI). Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- 12-lead electrocardiography
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Nov 2024to 31 Jan 2025
- 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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients assigned for non-cardiac surgeries who fulfilled the inclusion criteria underwent preoperative evaluation using the assessment tools. All patients were admitted to the intermediate care unit for the 1st 24-h PO for follow-up for the possibility of developing acute myocardial infarction (AMI), which was diagnosed according to the 2017 ESC Guidelines and was differentiated as STEMI and NSTEMI.
Who may be able to join
- Patients older than 45,
- Patients of ASA-PS grade II-IV,
- Patients who prepared for non-cardiac surgeries of SSS of II-IV,
- Patients free of exclusion criteria,
- Patients signed the written consent for the study precipitation.
Who cannot join
- Patients of ASA-PS grade I or V,
- Patients younger than 60 years,
- Patients planned to undergo surgeries of SSS >IV,
- Patients were severely frail with CFS>6,
- Patients had abnormal preoperative electrocardiography (ECG),
- Patients had a history of previous major cardiac or cerebrovascular events,
- Patient had disturbed cognitive function, coagulopathy, severe anemia with hemoglobin concentration (HBC) < 7 gm/dl.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Scoring and Biomarkers for Prediction of Myocardial Infarction After Non-Cardiac Surgery (MINS) Syndrome in Patients Undergoing Major Abdominal Surgeries
All patients undergoing non-cardiac surgery who met the inclusion criteria underwent a preoperative evaluation using specific assessment tools.
Following surgery, patients were closely monitored in the intermediate care unit for the first 24 hours for the development of acute myocardial infarction (AMI). AMI was diagnosed based on the presence of chest pain, elevated cardiac biomarkers, and specific electrocardiogram (ECG) and echocardiogram findings.
- Conditions
- Myocardial Infarction
- Being tested
- 12-lead electrocardiography
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12-lead electrocardiographyDiagnostic test
All patients were admitted to the intermediate care unit for the 1st 24-h PO for follow-up for the possibility of developing acute myocardial infarction (AMI), which was diagnosed according to the 2017 ESC Guidelines; by 12- lead electrocardiography
| Study group | Role | What they receive |
|---|---|---|
| Myocardial Infarction After Non-Cardiac Surgery (MINS) Syndrome Group | Not described Receives: Diagnostic Test: 12-lead electrocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients reported having at least a 50% incidence of Myocardial Infarction (measured by the Relevant Changes in 12-Leads ECG) in correlation with blood biomarkers.
The incidence of Myocardial infarction after major abdominal surgery detected by relevant changes in 12 leads ECG and in correlation to presence of blood biomarkers
Measured: 50 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start15 Nov 2024
- Primary completion1 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Abd ElRahman Hammed, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06767943
- Sponsor's protocol ID
- Rc 6-11-2024
- Status last verified
- Mar 2025
- First submitted
- 6 Jan 2025
- Last updated
- 1 Apr 2025
- 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 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Scoring and Biomarkers for Prediction of Myocardial Infarction After Non-Cardiac Surgery (MINS) Syndrome in Patients Undergoing Major Abdominal Surgeries
- ClinicalTrials.gov ID
- NCT06767943
- Acronym / sponsor ID
- Rc 6-11-2024
- Conditions
- Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 10 Jan 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.
All patients undergoing non-cardiac surgery who met the inclusion criteria underwent a preoperative evaluation using specific assessment tools.
Following surgery, patients were closely monitored in the intermediate care unit for the first 24 hours for the development of acute myocardial infarction (AMI). AMI was diagnosed based on the presence of chest pain, elevated cardiac biomarkers, and specific electrocardiogram (ECG) and echocardiogram findings.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Myocardial Infarction After Non-Cardiac Surgery (MINS) Syndrome Group | – | Diagnostic Test: 12-lead electrocardiography |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients assigned for non-cardiac surgeries who fulfilled the inclusion criteria underwent preoperative evaluation using the assessment tools. All patients were admitted to the intermediate care unit for the 1st 24-h PO for follow-up for the possibility of developing acute myocardial infarction (AMI), which was diagnosed according to the 2017 ESC Guidelines and was differentiated as STEMI and NSTEMI.
Key inclusion criteria (5 listed)
- Patients older than 45,
- Patients of ASA-PS grade II-IV,
- Patients who prepared for non-cardiac surgeries of SSS of II-IV,
- Patients free of exclusion criteria,
- Patients signed the written consent for the study precipitation.
Key exclusion criteria (7 listed)
- Patients of ASA-PS grade I or V,
- Patients younger than 60 years,
- Patients planned to undergo surgeries of SSS >IV,
- Patients were severely frail with CFS>6,
- Patients had abnormal preoperative electrocardiography (ECG),
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 |
|---|---|---|
| 12-lead electrocardiographyAll patients were admitted to the intermediate care unit for the 1st 24-h PO for follow-up for the possibility of developing acute myocardial infarction (AMI), which was diagnosed according to the 2017 ESC Guidelines; by 12- lead electrocardiography | Diagnostic test | Myocardial Infarction After Non-Cardiac Surgery (MINS) Syndrome Group |
Primary outcome
The proportion of patients reported having at least a 50% incidence of Myocardial Infarction (measured by the Relevant Changes in 12-Leads ECG) in correlation with blood biomarkers.
Time frame: 50 Days
The incidence of Myocardial infarction after major abdominal surgery detected by relevant changes in 12 leads ECG and in correlation to presence of blood biomarkers
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
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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.
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 Myocardial Infarction, run by Benha University at 1 site in Egypt.
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 1 Apr 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The proportion of patients reported having at least a 50% incidence of Myocardial Infarction (measured by the Relevant Changes in 12-Leads ECG) in correlation with blood biomarkers. (time frame: 50 Days). 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 1 Apr 2025.