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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-01

Study Completion Date

2026-01-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Left Ventricular Global Longitudinal Strain and Postoperative Myocardial Injury

NCT05392426

Postoperative Complications

UNKNOWN

Hemodynamic, Vascular and Muscular Parameters of Exercise Capacity in Single-Ventricle Patients With Fontan Procedure

NCT05011565

Single-ventricle Fontan Procedure Hemodynamic Instability +3 more

COMPLETED

Cardiovascular Assessment of Pediatric Cancer Survivors

NCT05939089

Left Ventricular Dysfunction Heart Failure

COMPLETED

Evaluation of Monitoring TECHNOlogies in the PERI-OPerative Care of Cardiac Surgical Patients

NCT02658006

C.Surgical Procedure; Cardiac Right-Sided Heart Failure Acute Kidney Injury +2 more

COMPLETED

Upper Extremity Function in Patients With Reduced Ejection Fraction Heart Failure and Cardiac Implantable Electronic Devices

NCT07253909

Heart Failure Implantable Cardioverter Defibrillator (ICD) Cardiac Resynchronisation Therapy (CRT) +1 more

ENROLLING_BY_INVITATION

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Myocardial Ischemia Diabetes Complication

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

high sensitive Troponin I

Intervention Type DIAGNOSTIC_TEST

High sensitive Troponin I used to predict myocardial damage

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

high sensitive Troponin I

High sensitive Troponin I used to predict myocardial damage

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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