Evaluation of Perioperative Myocardial Injury in Patients Undergoing Below-Knee Lower Extremity Surgery

NCT07241572 | Recruiting

• 1 other identifier: E2-25-11354
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Myocardial Ischemia; Diabetes Complication

Keywords

myocardial injury; Troponın I; diabetic neuropaty; MINS

Outcome Measures

Primary Outcomes (3)

• High sensitive Troponin I

  peroperative High sensitive Troponin I

  01.09.2025-10.01.2026

• High sensitive Troponin I

  postoperative 24th hour High sensitive Troponin I

  01.09.2025-11.01.2026

• High sensitive Troponin I

  postoperative 48th hour High sensitive Troponin I

  01.09.2025-12.01.2026

Secondary Outcomes (3)

• hemodynamic parameters 1

  01.09.2025-10.01.2026

• hemodynamic parameters 2

  01.09.2025-10.01.2026

• hemodynamic parameters 3

  01.09.2025-10.01.2026

Other Outcomes (4)

• unexpected events

  01.09.2025-10.02.2026

• unexpected events

  01.09.2025-11.02.2026

• unexpected events

  01.09.2025-12.02.2026

Study Arms (1)

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).

Diagnostic Test: high sensitive Troponin I

Interventions

high sensitive Troponin I DIAGNOSTIC_TEST

High sensitive Troponin I used to predict myocardial damage

All patients undergoing elective below-knee lower extremity surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing below-knee lower extremity surgery under peripheral nerve blockade

You may qualify if:

• 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

You may not qualify if:

• Patients in whom regional anesthesia is contraindicated
• Patients who refuse to participate in the study

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• 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.

  PMID: 32812403 RESULT

• Horr 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.

  PMID: 26366956 RESULT

• Devereaux 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.

  PMID: 31095334 RESULT

MeSH Terms

Conditions

Myocardial Ischemia; Diabetes Complications

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Harun Zengin

  harunzengin71@gmail.com

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Harun Zengin

CONTACT

05422358195; harunzengin71@gmail.com

Semih Baskan

CONTACT

05326030675; drsemkan@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 21, 2025
• Study Start: September 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: January 10, 2026
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)