NCT07098468

Brief Summary

The aim of this study is to determine the incidence of myocardial injury after noncardiac surgery (MINS) in patients undergoing elective total knee or hip arthroplasty, and to identify the demographic, clinical, laboratory, and surgical risk factors that may contribute to its development.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
323

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 1, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

August 3, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

6 months

First QC Date

July 14, 2025

Last Update Submit

February 11, 2026

Conditions

Keywords

Myocardial injury, noncardiac surgery

Outcome Measures

Primary Outcomes (1)

  • Ischemia-related myocardial damage after noncardiac surgery

    Diagnostic Biochemical Criteria for MINS: Myocardial Injury after Non-Cardiac Surgery (MINS) is defined when at least one of the following high-sensitivity cardiac troponin T (hs-cTnT) criteria is met: A postoperative hs-cTnT level of at least 20 ng/L combined with a minimum absolute increase of 5 ng/L from the preoperative value, or An absolute postoperative hs-cTnT concentration of ≥ 65 ng/L, regardless of baseline values. These threshold values are used to detect subclinical myocardial injury due to ischemia that occurs after surgery, even in the absence of ischemic symptoms or electrocardiographic changes. In this study, patients meeting at least one of the above criteria within 30 days postoperatively will be classified as having MINS.

    After surgery 30 days

Secondary Outcomes (1)

  • Causes of myocardial damage due to ischemia following noncardiac surgery

    30 days

Study Arms (2)

Mins positivity

Patients with high sensitive troponin positivity after surgery

Mins Negative

Patients with negative high sensitive troponin after surgery

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study is planned to include 314 patients aged 45 and older undergoing elective hip or knee arthroplasty. Participants will be accepted for participation with physician approval and a voluntary consent form.

You may qualify if:

  • Age over 45
  • Elective total knee or hip replacement

You may not qualify if:

  • Those undergoing cardiac surgery
  • History of acute MI (\<30 days)
  • Chronic elevation of troponin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara City Hospital Bilkent

Ankara, 06800, Turkey (Türkiye)

Location

Study Officials

  • Mehmet Şahap

    Sahap

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asist prof

Study Record Dates

First Submitted

July 14, 2025

First Posted

August 1, 2025

Study Start

August 3, 2025

Primary Completion

February 1, 2026

Study Completion

February 1, 2026

Last Updated

February 13, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Due to the inadequate database network, patient information will not be shared with third parties. Patient data may be shared with journals upon request.

Locations