Myocardial IschemiaNCT07241572
Evaluation of Perioperative Myocardial Injury in Patients Undergoing Below-Knee Lower Extremity Surgery
An observational study of Myocardial Ischemia and Diabetes Complication, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
The aim of this observational study was to detect myocardial damage by monitoring high-sensitive troponin I levels in patients undergoing below-knee extremity surgery with peripheral nerve block. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myocardial Ischemia, Diabetes Complication
- What is being tested?
- high sensitive Troponin I
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 10 Jan 2026
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing below-knee lower extremity surgery under peripheral nerve blockade
Who may be able to join
- Patients over 18 years of age
- Patients undergoing below-knee lower extremity surgery
- Patients with ASA classifications I, II, III, and IV
- Patients who have consented before the procedure
- Patients who are literate and able to give consent
Who cannot join
- Patients in whom regional anesthesia is contraindicated
- Patients who refuse to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Bilkent City Hospital
Ankara
Harun Zengin, 05422358195, harunzengin71@gmail.com
About this study
Official title: Evaluation of Perioperative Myocardial Injury in Patients Undergoing Below-knee Lower Extremity Surgery With Peripheral Nerve Block
The aim of this observational study was to detect myocardial damage by monitoring high-sensitive troponin I levels in patients undergoing below-knee extremity surgery with peripheral nerve block.
The primary question it aims to answer is:
How effective are peroperative high-sensitive troponin I levels in predicting myocardial damage?
High-sensitive troponin I levels will be monitored intraoperatively and at 24 and 48 hours postoperatively.
Read the detailed description
Peripheral nerve blocks are becoming increasingly popular in foot and ankle surgery. Patients undergoing peripheral nerve blocks have advantages such as shorter hospital stays, better postoperative pain relief, lower costs, and less opioid use.
A review of current literature revealed that myocardial damage has not been investigated in patients scheduled for below-knee lower extremity surgery. Therefore, we aimed to detect myocardial damage by monitoring high-sensitive troponin I levels, which is considered the most sensitive and effective test according to AHA/ACC (American College of Cardiology and American Heart Association) guidelines at our hospital. The secondary aim of the study was to determine which parameters correlate with myocardial damage.
Preoperatively, the patient's hemogram, biochemistry, and hsTroponin I measurements, all of which were requested during the preparation phase, will be recorded.
During the operation, the type of anesthesia, the amount of local anesthetic and adjuvant medication used for peripheral nerve blockade will be recorded.
Intraoperatively, routine anesthetic monitoring (SpO2, blood pressure, ECG, heart rate), intraoperative presence and duration of hypotension, need for inotropic support, total dose (if any), presence and duration of tachycardia and bradycardia, fluid volume administered, urine output, and operation time will be recorded.
Postoperatively, all patients will be monitored in their ward or intensive care unit. Routine hemogram, biochemistry, and hsTroponin I measurements will be repeated at 24 and 48 hours, and the results will be noted. Postoperative complications will be recorded.
Patients will be followed up for 30 days through the hospital registry and telemedicine at the investigator's discretion, and will be questioned about potential major cardiac events (MACE).
- Conditions
- Myocardial Ischemia, Diabetes Complication
- Being tested
- high sensitive Troponin I
- Keywords
- myocardial injury, Troponın I, diabetic neuropaty, MINS
- Medical subject headings
- Myocardial Ischemia, Diabetes Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high sensitive Troponin IDiagnostic test
High sensitive Troponin I used to predict myocardial damage
| Study group | Role | What they receive |
|---|---|---|
| All patients undergoing elective below-knee lower extremity surgery | All patients undergoing below-knee lower extremity surgery will have their high-sensitive troponin I levels monitored preoperatively and at the 24th and 48th hours postoperatively.
Intraoperatively, routine anesthetic monitoring (SpO2, blood pressure, ECG, apical heart rate) will be recorded. The presence and duration of intraoperative hypotension, the need for inotropic support, the total dose (if any), the presence and duration of tachycardia and bradycardia, the amount of fluid administered, urine output, and the duration of surgery will be recorded.
Postoperative complications will be recorded. Patients will be followed up for 30 days through the hospital registry and telemedicine at the investigator's discretion, and will be questioned about potential major cardiac events (MACE). Receives: Diagnostic Test: high sensitive Troponin I |
What is being measured
The primary outcome is the main question the study is designed to answer.
High sensitive Troponin I
peroperative High sensitive Troponin I
Measured: 01.09.2025-10.01.2026
High sensitive Troponin I
postoperative 24th hour High sensitive Troponin I
Measured: 01.09.2025-11.01.2026
High sensitive Troponin I
postoperative 48th hour High sensitive Troponin I
Measured: 01.09.2025-12.01.2026
Secondary outcomes (3)
hemodynamic parameters 1
intraoperative blood pressure (mmHg)
Measured: 01.09.2025-10.01.2026
hemodynamic parameters 2
intraoperative oxygen saturation (%)
Measured: 01.09.2025-10.01.2026
hemodynamic parameters 3
heart rate (/min)
Measured: 01.09.2025-10.01.2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start1 Sep 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion10 Jan 2026 (estimated)
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 IschemiaStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Harun Zengin, Principal investigator, harunzengin71@gmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07241572
- Sponsor's protocol ID
- E2-25-11354
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: general demographic information, contact information, work names
Publications
Park J, Hyeon CW, Lee SH, Kim J, Kwon JH, Yang K, Min JJ, Lee JH, Lee SM, Yang JH, Song YB, Hahn JY, Choi JH, Choi SH, Kim K, Ahn J, Gwon HC. Mildly Elevated Cardiac Troponin below the 99th-Percentile Upper Reference Limit after Noncardiac Surgery. Korean Circ J. 2020 Oct;50(10):925-937. doi: 10.4070/kcj.2020.0088. Epub 2020 Jul 24.
PubMed 32812403Horr S, Reed G, Menon V. Troponin elevation after noncardiac surgery: Significance and management. Cleve Clin J Med. 2015 Sep;82(9):595-602. doi: 10.3949/ccjm.82a.15076.
PubMed 26366956Devereaux PJ, Szczeklik W. Myocardial injury after non-cardiac surgery: diagnosis and management. Eur Heart J. 2020 May 1;41(32):3083-3091. doi: 10.1093/eurheartj/ehz301.
PubMed 31095334
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Perioperative Myocardial Injury in Patients Undergoing Below-knee Lower Extremity Surgery With Peripheral Nerve Block
- ClinicalTrials.gov ID
- NCT07241572
- Acronym / sponsor ID
- E2-25-11354
- Conditions
- Myocardial Ischemia, Diabetes Complication
- Keywords
- myocardial injury, Troponın I, diabetic neuropaty, MINS
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 10 Jan 2026 (estimated)
- First posted
- 21 Nov 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.
The aim of this observational study was to detect myocardial damage by monitoring high-sensitive troponin I levels in patients undergoing below-knee extremity surgery with peripheral nerve block.
The primary question it aims to answer is:
How effective are peroperative high-sensitive troponin I levels in predicting myocardial damage?
High-sensitive troponin I levels will be monitored intraoperatively and at 24 and 48 hours postoperatively.
Detailed description
Peripheral nerve blocks are becoming increasingly popular in foot and ankle surgery. Patients undergoing peripheral nerve blocks have advantages such as shorter hospital stays, better postoperative pain relief, lower costs, and less opioid use.
A review of current literature revealed that myocardial damage has not been investigated in patients scheduled for below-knee lower extremity surgery. Therefore, we aimed to detect myocardial damage by monitoring high-sensitive troponin I levels, which is considered the most sensitive and effective test according to AHA/ACC (American College of Cardiology and American Heart Association) guidelines at our hospital. The secondary aim of the study was to determine which parameters correlate with myocardial damage.
Preoperatively, the patient's hemogram, biochemistry, and hsTroponin I measurements, all of which were requested during the preparation phase, will be recorded.
During the operation, the type of anesthesia, the amount of local anesthetic and adjuvant medication used for peripheral nerve blockade will be recorded.
Intraoperatively, routine anesthetic monitoring (SpO2, blood pressure, ECG, heart rate), intraoperative presence and duration of hypotension, need for inotropic support, total dose (if any), presence and duration of tachycardia and bradycardia, fluid volume administered, urine output, and operation time will be recorded.
Postoperatively, all patients will be monitored in their ward or intensive care unit. Routine hemogram, biochemistry, and hsTroponin I measurements will be repeated at 24 and 48 hours, and the results will be noted. Postoperative complications will be recorded.
Patients will be followed up for 30 days through the hospital registry and telemedicine at the investigator's discretion, and will be questioned about potential major cardiac events (MACE).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients undergoing elective below-knee lower extremity surgery | – | Diagnostic Test: high sensitive Troponin IAll patients undergoing below-knee lower extremity surgery will have their high-sensitive troponin I levels monitored preoperatively and at the 24th and 48th hours postoperatively. Intraoperatively, routine anesthetic monitoring (SpO2, blood pressure, ECG, apical heart rate) will be recorded. The presence and duration of intraoperative hypotension, the need for inotropic support, the total dose (if any), the presence and duration of tachycardia and bradycardia, the amount of fluid administered, urine output, and the duration of surgery will be recorded. Postoperative complications will be recorded. Patients will be followed up for 30 days through the hospital registry and telemedicine at the investigator's discretion, and will be questioned about potential major cardiac events (MACE). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing below-knee lower extremity surgery under peripheral nerve blockade
Key inclusion criteria (5 listed)
- Patients over 18 years of age
- Patients undergoing below-knee lower extremity surgery
- Patients with ASA classifications I, II, III, and IV
- Patients who have consented before the procedure
- Patients who are literate and able to give consent
Key exclusion criteria (2 listed)
- Patients in whom regional anesthesia is contraindicated
- Patients who refuse to participate in the study
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 |
|---|---|---|
| high sensitive Troponin IHigh sensitive Troponin I used to predict myocardial damage | Diagnostic test | All patients undergoing elective below-knee lower extremity surgery |
Primary outcome
High sensitive Troponin I
Time frame: 01.09.2025-10.01.2026
peroperative High sensitive Troponin I
High sensitive Troponin I
Time frame: 01.09.2025-11.01.2026
postoperative 24th hour High sensitive Troponin I
High sensitive Troponin I
Time frame: 01.09.2025-12.01.2026
postoperative 48th hour High sensitive Troponin I
3 secondary outcomes
hemodynamic parameters 1
Time frame: 01.09.2025-10.01.2026
hemodynamic parameters 2
Time frame: 01.09.2025-10.01.2026
hemodynamic parameters 3
Time frame: 01.09.2025-10.01.2026
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 1 Dec 2025.
- Results publication: PubMed 32812403Park J, Hyeon CW, Lee SH, Kim J, Kwon JH, Yang K, Min JJ, Lee JH, Lee SM, Yang JH, Song YB, Hahn JY, Choi JH, Choi SH, Kim K, Ahn J, Gwon HC. Mildly Elevated Cardiac Troponin below the 99th-Percentile Upper Reference Limit after Noncardiac Surgery. Korean Circ J. 2020 Oct;50(10):925-937. doi: 10.4070/kcj.2020.0088. Epub 2020 Jul 24.
- Results publication: PubMed 26366956Horr S, Reed G, Menon V. Troponin elevation after noncardiac surgery: Significance and management. Cleve Clin J Med. 2015 Sep;82(9):595-602. doi: 10.3949/ccjm.82a.15076.
- Results publication: PubMed 31095334Devereaux PJ, Szczeklik W. Myocardial injury after non-cardiac surgery: diagnosis and management. Eur Heart J. 2020 May 1;41(32):3083-3091. doi: 10.1093/eurheartj/ehz301.
- Individual participant dataSharing planned: No. general demographic information, contact information, work names
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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.
Harun Zengin principal investigator
harunzengin71@gmail.com
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 Ischemia and Diabetes Complication, run by Ankara City Hospital Bilkent 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 5 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 1 Dec 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?
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 Harun Zengin (05422358195, harunzengin71@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High sensitive Troponin I (time frame: 01.09.2025-10.01.2026). The study lists 3 primary outcomes in all. 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 NCT07241572, 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 1 Dec 2025.