Myocardial Injury After Noncardiac Surgery (MINS)NCT06957106
Myocardial Injury Noncardiac Surgery in Geriatric Patients
An observational study of Myocardial Injury After Noncardiac Surgery (MINS), run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In inpatients aged 45 years and older, the approximate peri-operative mortality rate after non-cardiac surgery is around 1% to 2%. Half of these deaths are attributed to cardiovascular complications of surgery. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Myocardial Injury After Noncardiac Surgery (MINS)
- How many people
- 117 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 1 Aug 2023
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: This study includes geriatric patients aged 65 years and older who underwent major, moderate, or minor surgery under general and/or regional anesthesia and were followed postoperatively in the intensive care unit between January 2018 and August 2023 at Fatih Sultan Mehmet Training and Research Hospital. The study population consists of patients whose medical records were retrospectively reviewed.
Who may be able to join
- Patients aged 65 years or older
- Patients who underwent major, moderate, or minor surgery under general and/or regional anesthesia
- Patients who were followed and treated in the postoperative intensive care unit
Who cannot join
- Patients younger than 65 years of age
- Patients with preoperative troponin levels above the normal reference range
- Patients with active myocardial ischemia symptoms (e.g., chest pain, pain radiating to the neck, jaw, shoulder, or arm)
- Patients with known pre-existing cardiac disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Fatih Sultan Mehmet Training and Research Hospital,
Istanbul, Atasehir, 34752
About this study
Official title: Myocardial Injury in Geriatric Patients Followed in Intensive Care Unit After Noncardiac Surgery
In inpatients aged 45 years and older, the approximate peri-operative mortality rate after non-cardiac surgery is around 1% to 2%. Half of these deaths are attributed to cardiovascular complications of surgery. Postoperative cardiac troponin elevation with ≥1 measurement of cardiac troponin ≥99% percentile above the upper limit of the reference value, which is an indicator of acute myocardial injury, is seen in the first 30 days after surgery and usually occurs within 72 hours. Myocardial damage is thought to result from an ischemic mechanism. Clinical symptoms may be masked by sedation or analgesia in the perioperative period, so evidence of an ischemic feature (e.g. ischemic symptoms, electrocardiographic changes) is not required. These criteria are defined as MINS (Myocardial Injury Non Cardiac Surgery) criteria. In this study, the investigators aimed to investigate the intensive care follow-up processes and outcomes of geriatric patients over 65 years of age in whom MINS was detected during postoperative intensive care monitoring.
Read the detailed description
In this study study, 117 geriatric patients aged ≥65 years who were followed and treated in the intensive care unit in the postoperative period after general or regional anesthesia between January 2018 and August 2023 after obtaining Ethics Committee Approval (FSM EAH-KAEK 2023/140) were retrospectively analyzed. Age, gender, comorbidities, coronary artery disease, heart failure, atrial fibrillation, history of chronic renal failure, presence of emergency surgery, preoperative antiaggregant use, ASA score, type of surgery, presence of laparoscopic or open surgery, anesthesia and duration of surgery, intra operatively; hypotension, tachycardia, bradycardia, presence of blood and blood products transfusion, duration if hypotension developed, first day of intensive care unit hospitalization; APACHE, SAPS, SOFA scores, duration of mechanical ventilation, presence and duration of troponin elevation, the day of hospitalization, if cardiac examination was performed; Ejection fraction, diastolic dysfunction, presence of revascularization treatment, hemoglobin, hematocrit levels on the day of troponin elevation, neutrophil/lymphocyte ratio, procalcitonin, crp levels, use of antiaggregants, mechanical thrombophylaxis, acidosis, presence of hypoxia, need for vasopressor therapy, type of discharge from intensive care unit and presence of mortality will be recorded
- Keywords
- myocardial injury, intensive care unit, geriatric patients, troponin elevation, ICU outcomes, Anesthesia
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 |
|---|---|---|
| Geriatric ICU Patients | Geriatric patients (aged ≥65 years) who underwent surgery under general or regional anesthesia and were admitted to the intensive care unit in the postoperative period between January 2018 and August 2023. |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day postoperative mortality
Association between postoperative troponin elevation and ICU mortality in geriatric patients. Mortality status recorded in hospital database
Measured: 30 days
Secondary outcomes (1)
mechanical ventilation
Duration of mechanical ventilation in patients over 65 years of age with postoperative mins.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start1 Jan 2018
- Primary completion1 Aug 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Myocardial Injury After Noncardiac Surgery (MINS)Studies 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
- Retrospective
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Berkehan Nizamlıoğlu, Fatih Sultan Mehmet Training and Research Hospital
- Investigators
- Arzu Yildirim Ar, As Prof, Study director, Fatih Sultan Mehmet Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06957106
- Sponsor's protocol ID
- FSMTRH-MBN-02
- Status last verified
- Jan 2025
- First submitted
- 21 Apr 2025
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is a retrospective observational study. Individual participant data will not be shared.
Publications
Gao L, Chen L, He J, Wang B, Liu C, Wang R, Fan L, Cheng R. Perioperative Myocardial Injury/Infarction After Non-cardiac Surgery in Elderly Patients. Front Cardiovasc Med. 2022 May 19;9:910879. doi: 10.3389/fcvm.2022.910879. eCollection 2022.
PubMed 35665266Park J, Lee JH. Myocardial injury in noncardiac surgery. Korean J Anesthesiol. 2022 Feb;75(1):4-11. doi: 10.4097/kja.21372. Epub 2021 Oct 18.
PubMed 34657407Ruetzler K, Smilowitz NR, Berger JS, Devereaux PJ, Maron BA, Newby LK, de Jesus Perez V, Sessler DI, Wijeysundera DN. Diagnosis and Management of Patients With Myocardial Injury After Noncardiac Surgery: A Scientific Statement From the American Heart Association. Circulation. 2021 Nov 9;144(19):e287-e305. doi: 10.1161/CIR.0000000000001024. Epub 2021 Oct 4.
PubMed 34601955
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocardial Injury in Geriatric Patients Followed in Intensive Care Unit After Noncardiac Surgery
- ClinicalTrials.gov ID
- NCT06957106
- Acronym / sponsor ID
- FSMTRH-MBN-02
- Keywords
- myocardial injury, intensive care unit, geriatric patients, troponin elevation, ICU outcomes, Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 4 May 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.
In inpatients aged 45 years and older, the approximate peri-operative mortality rate after non-cardiac surgery is around 1% to 2%. Half of these deaths are attributed to cardiovascular complications of surgery. Postoperative cardiac troponin elevation with ≥1 measurement of cardiac troponin ≥99% percentile above the upper limit of the reference value, which is an indicator of acute myocardial injury, is seen in the first 30 days after surgery and usually occurs within 72 hours. Myocardial damage is thought to result from an ischemic mechanism. Clinical symptoms may be masked by sedation or analgesia in the perioperative period, so evidence of an ischemic feature (e.g. ischemic symptoms, electrocardiographic changes) is not required. These criteria are defined as MINS (Myocardial Injury Non Cardiac Surgery) criteria. In this study, the investigators aimed to investigate the intensive care follow-up processes and outcomes of geriatric patients over 65 years of age in whom MINS was detected during postoperative intensive care monitoring.
Detailed description
In this study study, 117 geriatric patients aged ≥65 years who were followed and treated in the intensive care unit in the postoperative period after general or regional anesthesia between January 2018 and August 2023 after obtaining Ethics Committee Approval (FSM EAH-KAEK 2023/140) were retrospectively analyzed. Age, gender, comorbidities, coronary artery disease, heart failure, atrial fibrillation, history of chronic renal failure, presence of emergency surgery, preoperative antiaggregant use, ASA score, type of surgery, presence of laparoscopic or open surgery, anesthesia and duration of surgery, intra operatively; hypotension, tachycardia, bradycardia, presence of blood and blood products transfusion, duration if hypotension developed, first day of intensive care unit hospitalization; APACHE, SAPS, SOFA scores, duration of mechanical ventilation, presence and duration of troponin elevation, the day of hospitalization, if cardiac examination was performed; Ejection fraction, diastolic dysfunction, presence of revascularization treatment, hemoglobin, hematocrit levels on the day of troponin elevation, neutrophil/lymphocyte ratio, procalcitonin, crp levels, use of antiaggregants, mechanical thrombophylaxis, acidosis, presence of hypoxia, need for vasopressor therapy, type of discharge from intensive care unit and presence of mortality will be recorded
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Geriatric ICU Patients | – | –Geriatric patients (aged ≥65 years) who underwent surgery under general or regional anesthesia and were admitted to the intensive care unit in the postoperative period between January 2018 and August 2023. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- This study includes geriatric patients aged 65 years and older who underwent major, moderate, or minor surgery under general and/or regional anesthesia and were followed postoperatively in the intensive care unit between January 2018 and August 2023 at Fatih Sultan Mehmet Training and Research Hospital. The study population consists of patients whose medical records were retrospectively reviewed.
Key inclusion criteria (3 listed)
- Patients aged 65 years or older
- Patients who underwent major, moderate, or minor surgery under general and/or regional anesthesia
- Patients who were followed and treated in the postoperative intensive care unit
Key exclusion criteria (4 listed)
- Patients younger than 65 years of age
- Patients with preoperative troponin levels above the normal reference range
- Patients with active myocardial ischemia symptoms (e.g., chest pain, pain radiating to the neck, jaw, shoulder, or arm)
- Patients with known pre-existing cardiac disease
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
30-day postoperative mortality
Time frame: 30 days
Association between postoperative troponin elevation and ICU mortality in geriatric patients. Mortality status recorded in hospital database
1 secondary outcome
mechanical ventilation
Time frame: 30 days
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 4 May 2025.
- Results publication: PubMed 35665266Gao L, Chen L, He J, Wang B, Liu C, Wang R, Fan L, Cheng R. Perioperative Myocardial Injury/Infarction After Non-cardiac Surgery in Elderly Patients. Front Cardiovasc Med. 2022 May 19;9:910879. doi: 10.3389/fcvm.2022.910879. eCollection 2022.
- Results publication: PubMed 34657407Park J, Lee JH. Myocardial injury in noncardiac surgery. Korean J Anesthesiol. 2022 Feb;75(1):4-11. doi: 10.4097/kja.21372. Epub 2021 Oct 18.
- Results publication: PubMed 34601955Ruetzler K, Smilowitz NR, Berger JS, Devereaux PJ, Maron BA, Newby LK, de Jesus Perez V, Sessler DI, Wijeysundera DN. Diagnosis and Management of Patients With Myocardial Injury After Noncardiac Surgery: A Scientific Statement From the American Heart Association. Circulation. 2021 Nov 9;144(19):e287-e305. doi: 10.1161/CIR.0000000000001024. Epub 2021 Oct 4.
- Individual participant dataSharing planned: No. This is a retrospective observational study. Individual participant data will not be shared.
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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.
Arzu Yildirim Ar, As Prof study director
Fatih Sultan Mehmet Training and Research 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 Myocardial Injury After Noncardiac Surgery (MINS), run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
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 3 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: finished, as of the sponsor's last update on 4 May 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 Turkey (Türkiye). 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?
30-day postoperative mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06957106, which also lists 3 linked publications.
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 4 May 2025.