NCT06957106

Brief Summary

In inpatients aged 45 years and older, the approximate peri-operative mortality rate after non-cardiac surgery is around 1% to 2%. Half of these deaths are attributed to cardiovascular complications of surgery. Postoperative cardiac troponin elevation with ≥1 measurement of cardiac troponin ≥99% percentile above the upper limit of the reference value, which is an indicator of acute myocardial injury, is seen in the first 30 days after surgery and usually occurs within 72 hours. Myocardial damage is thought to result from an ischemic mechanism. Clinical symptoms may be masked by sedation or analgesia in the perioperative period, so evidence of an ischemic feature (e.g. ischemic symptoms, electrocardiographic changes) is not required. These criteria are defined as MINS (Myocardial Injury Non Cardiac Surgery) criteria. In this study, the investigators aimed to investigate the intensive care follow-up processes and outcomes of geriatric patients over 65 years of age in whom MINS was detected during postoperative intensive care monitoring.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
117

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 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

Study Start

First participant enrolled

January 1, 2018

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

April 21, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 4, 2025

Completed
Last Updated

May 4, 2025

Status Verified

January 1, 2025

Enrollment Period

5.6 years

First QC Date

April 21, 2025

Last Update Submit

April 25, 2025

Conditions

Keywords

myocardial injuryintensive care unitgeriatric patientstroponin elevationICU outcomesAnesthesia

Outcome Measures

Primary Outcomes (1)

  • 30-day postoperative mortality

    Association between postoperative troponin elevation and ICU mortality in geriatric patients. Mortality status recorded in hospital database

    30 days

Secondary Outcomes (1)

  • mechanical ventilation

    30 days

Study Arms (1)

Geriatric ICU Patients

Geriatric patients (aged ≥65 years) who underwent surgery under general or regional anesthesia and were admitted to the intensive care unit in the postoperative period between January 2018 and August 2023.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study includes geriatric patients aged 65 years and older who underwent major, moderate, or minor surgery under general and/or regional anesthesia and were followed postoperatively in the intensive care unit between January 2018 and August 2023 at Fatih Sultan Mehmet Training and Research Hospital. The study population consists of patients whose medical records were retrospectively reviewed.

You may qualify if:

  • Patients aged 65 years or older
  • Patients who underwent major, moderate, or minor surgery under general and/or regional anesthesia
  • Patients who were followed and treated in the postoperative intensive care unit

You may not qualify if:

  • Patients younger than 65 years of age
  • Patients with preoperative troponin levels above the normal reference range
  • Patients with active myocardial ischemia symptoms (e.g., chest pain, pain radiating to the neck, jaw, shoulder, or arm)
  • Patients with known pre-existing cardiac disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fatih Sultan Mehmet Training and Research Hospital,

Istanbul, Atasehir, 34752, Turkey (Türkiye)

Location

Related Publications (3)

  • Gao L, Chen L, He J, Wang B, Liu C, Wang R, Fan L, Cheng R. Perioperative Myocardial Injury/Infarction After Non-cardiac Surgery in Elderly Patients. Front Cardiovasc Med. 2022 May 19;9:910879. doi: 10.3389/fcvm.2022.910879. eCollection 2022.

    PMID: 35665266BACKGROUND
  • Park J, Lee JH. Myocardial injury in noncardiac surgery. Korean J Anesthesiol. 2022 Feb;75(1):4-11. doi: 10.4097/kja.21372. Epub 2021 Oct 18.

    PMID: 34657407BACKGROUND
  • Ruetzler K, Smilowitz NR, Berger JS, Devereaux PJ, Maron BA, Newby LK, de Jesus Perez V, Sessler DI, Wijeysundera DN. Diagnosis and Management of Patients With Myocardial Injury After Noncardiac Surgery: A Scientific Statement From the American Heart Association. Circulation. 2021 Nov 9;144(19):e287-e305. doi: 10.1161/CIR.0000000000001024. Epub 2021 Oct 4.

    PMID: 34601955BACKGROUND

Study Officials

  • Arzu Yildirim Ar, As Prof

    Fatih Sultan Mehmet Training and Research Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor

Study Record Dates

First Submitted

April 21, 2025

First Posted

May 4, 2025

Study Start

January 1, 2018

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

May 4, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

This is a retrospective observational study. Individual participant data will not be shared.

Locations