Myocardial Injury After Noncardiac Surgery (MINS) in Lumb... | NCT07081009

Studies
Myocardial Injury After Noncardiac Surgery (MINS) in Lumbar Surgery Patients

NCT07081009

Sponsor

Ankara City Hospital Bilkent

Status

Recruiting

Last Update Posted

Oct 6, 2025Actual

Enrollment

180Estimated

Phase

Not provided

Conditions

MYOCARD INFARCTUS
Non Cardiac Surgery
Lumbar Surgery
Anesthesia

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2025Actual

Primary Completion Date

Mar 25, 2026Estimated

Completion Date

Apr 24, 2026Estimated

First Submitted Date

Jul 15, 2025

First Submission Date that Met QC Criteria

Jul 15, 2025

First Posted Date

Jul 23, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 1, 2025

Last Update Posted Date

Oct 6, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study is to evaluate the incidence of myocardial injury after noncardiac surgery (MINS) in patients undergoing lumbar surgery, and to investigate the associated risk factors.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

270 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

180Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mins positivity		Patients with high sensitive troponin positivity after surgery
Mins Negative		Patients with negative high sensitive troponin after surgery

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
1. Ischemia-related myocardial damage after noncardiac surgery	Ischemia-related myocardial damage occurring within 30 days after noncardiac surgery	After surgery 30 days

Secondary Outcomes

Measure	Description	Time Frame
2. Causes of myocardial damage due to ischemia following noncardiac surgery	To identify risk factors for myocardial damage due to ischemia following noncardiac surgery.	30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria Age ≥18 years Elective lumbar stabilization surgery

Exclusion criteria History of cardiac surgery Recent acute MI (<30 days) Chronic elevated troponin levels

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

A total of 180 patients aged 18 years and older who are scheduled to undergo elective lumbar stabilization will be included. Participants will be enrolled upon physician approval and informed consent.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mehmet Şahap	Contact	05336826254		drsahap@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ankara City Hospital Bilkent	Recruiting	Ankara		06800	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided