- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06957106
Myocardial Injury Noncardiac Surgery in Geriatric Patients
April 25, 2025 updated by: Mustafa Berkehan Nizamlıoğlu, Fatih Sultan Mehmet Training and Research Hospital
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.
Study Overview
Status
Completed
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 Type
Observational
Enrollment (Actual)
117
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Atasehir
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Istanbul, Atasehir, Turkey, 34752
- Fatih Sultan Mehmet Training and Research Hospital,
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
mechanical ventilation
Time Frame: 30 days
|
Duration of mechanical ventilation in patients over 65 years of age with postoperative mins.
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Arzu Yildirim Ar, As Prof, Fatih Sultan Mehmet Training and Research Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Ruetzler 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.
- 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.
- Park 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2018
Primary Completion (Actual)
August 1, 2023
Study Completion (Actual)
August 1, 2023
Study Registration Dates
First Submitted
April 21, 2025
First Submitted That Met QC Criteria
April 25, 2025
First Posted (Actual)
May 4, 2025
Study Record Updates
Last Update Posted (Actual)
May 4, 2025
Last Update Submitted That Met QC Criteria
April 25, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FSMTRH-MBN-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
This is a retrospective observational study.
Individual participant data will not be shared.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.