NCT03605134

Brief Summary

To document levels of cardiac troponin hsTnT in patients above 75y undergoing high risk surgery and the relationship between elevated levels and outcome in terms of hospital stay and 30 day mortality.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
63

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

June 28, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 30, 2018

Completed
24 days until next milestone

Study Start

First participant enrolled

August 23, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 7, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 7, 2019

Completed
Last Updated

November 18, 2025

Status Verified

October 1, 2025

Enrollment Period

12 months

First QC Date

June 28, 2018

Last Update Submit

November 14, 2025

Conditions

Surgery--ComplicationsMortalityElderly

Keywords

troponindiastolic function

Outcome Measures

Primary Outcomes (1)

  • surgical mortality

    30 days mortality

    30 days

Secondary Outcomes (1)

  • diastolic function

    3 days

Study Arms (1)

study group

level of cardiac troponin and diastolic function assessment by means of transthoracic echocardiography

Diagnostic Test: level of cardiac troponinDiagnostic Test: diastolic function assessment

Interventions

level of cardiac troponinDIAGNOSTIC_TEST

blood test

study group
diastolic function assessmentDIAGNOSTIC_TEST

transthoracic echocardiography

study group

Eligibility Criteria

Age75 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

All surgical patients above 75 years old

You may qualify if:

  • All patients ≥75 y undergoing elective and major surgery till we have collected an entire dataset of 100 patients.
  • Only those patients will be included who are planned for elective and major surgery.

You may not qualify if:

  • Patients under the age of 75
  • Intraoperative mortality
  • Eye surgery
  • Cardiac or thoracic surgery
  • Patients undergoing surgery which is not withheld as major surgery
  • For patients undergoing multiple surgeries for the same indication and during the same hospitalization, only the first surgery will be included

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitair Ziekenhuis Brussel

Jette, Vlaams Brabant, 1090, Belgium

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample: High sensitive Troponin T

Study Officials

  • jan Poelaert, PhD, MD

    Universitair Ziekenhuis Brussel

    PRINCIPAL INVESTIGATOR

  • Patrice Forget, PhD, MD

    Universitair Ziekenhuis Brussel

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

June 28, 2018

First Posted

July 30, 2018

Study Start

August 23, 2018

Primary Completion

August 7, 2019

Study Completion

August 7, 2019

Last Updated

November 18, 2025

Record last verified: 2025-10

Locations

BE(1)