NCT05778981

Brief Summary

Endothelial dysfunction is a cardiovascular disease hallmark. After non-cardiac surgery, cardiovascular events correlate with surgical outcomes. Understanding the role of endothelial function in these events is crucial. This research aims to study endothelial function and its association with cardiovascular events.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

February 21, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

March 22, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

March 25, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

December 10, 2024

Status Verified

December 1, 2024

Enrollment Period

2.4 years

First QC Date

February 21, 2023

Last Update Submit

December 5, 2024

Conditions

SurgeryCardiac DeathStrokeMyocardial Injury

Keywords

FMDFlow-Mediated DilatationTroponin

Outcome Measures

Primary Outcomes (4)

  • Major Cardiac Events

    Result composed of myocardial infarction, cardiac arrest, and Death

    7 days after surgery

  • Major Cardiac Events

    Result composed of myocardial infarction, cardiac arrest, and Death

    1 month after surgery

  • Major Cardiac Events

    Result composed of myocardial infarction, cardiac arrest, and Death

    3 months after surgery

  • Major Cardiac Events

    Result composed of myocardial infarction, cardiac arrest, and Death

    6 months after surgery

Secondary Outcomes (7)

  • Myocardial Injury

    1 day after surgery

  • Myocardial Injury

    2 days after surgery

  • Myocardial Injury

    3 days after surgery

  • Stroke

    7 days after surgery

  • Stroke

    1 month after surgery

  • +2 more secondary outcomes

Interventions

FMD - Troponin measurementDIAGNOSTIC_TEST

Echographic FMD evaluation. Pre and post-operative troponin measurements.

Eligibility Criteria

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

Patients scheduled for non-cardiac surgery of 45 years old and older.

You may qualify if:

  • Signed informed consent
  • Patients 45 years or older

You may not qualify if:

  • Refuse to participate in the study
  • Myocardial injury or acute myocardial infarction less than two weeks ago
  • Patients who expect less than 2 days of hospitalization
  • Patients in whom the troponin elevation is attributed to a secondary cause (for example, sepsis, pulmonary thromboembolism, electrical cardioversion, etc.)
  • Use of chemotherapy less than 2 weeks ago

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clínico de la Universidad de Chile

Independencia, Santiago Metropolitan, 8380456, Chile

RECRUITING

MeSH Terms

Conditions

DeathStroke

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Felipe Maldonado||, M.D.,M.Sc.

    Hospital Clinico de la Universidad de Chile

    STUDY CHAIR

Central Study Contacts

Felipe Maldonado, M.D., M.Sc.

CONTACT

+56 2 2978 8221fmaldonado@uchile.cl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 21, 2023

First Posted

March 22, 2023

Study Start

March 25, 2023

Primary Completion

August 1, 2025

Study Completion

December 1, 2025

Last Updated

December 10, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

CL(1)