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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04679077
Other study ID # MAPOVAS
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date February 1, 2021
Est. completion date February 1, 2022

Study information

Verified date May 2023
Source Universitair Ziekenhuis Brussel
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the study is to determine whether there is a correlation between the microcirculation measured preoperatively in patients undergoing major vascular surgery and the postoperative mortality during hospitalization period. The microcirculation will be measured sublingually with the Cytocam-IDF imaging technique.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date February 1, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age = 18 years - Males and females - ASA III classification - Written informed consent obtained by the patient - Elective hospital admission for major vascular surgery, both open and endovascular Exclusion Criteria: - Emergency surgery - Minor vascular procedures (e.g. varicose vein stripping; thromboembolectomy; vascular access formation) - Pregnancy - Refusal or inability to provide written informed consent (language barrier, mental retardation)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Cytocam-IDF imaging device
Observation of the microcirculation

Locations

Country Name City State
Belgium UZ Brussel Jette Brussel

Sponsors (1)

Lead Sponsor Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative high-sensitive troponin T (hsTnT) Indicator of acute coronary syndrome 30 days
Secondary Cause of death Causes of death 30 days
Secondary Non-cardiovascular adverse events and serious adverse events Incidence of non-cardiovascular complications 30 days
Secondary Cardiovascular adverse events and serious adverse events Incidence of cardiovascular complications 30 days
Secondary Correlation between preoperative microcirculation and postoperative outcome during the hospitalization period. In addition, demographic parameters (age, weight, height) and comorbidities will be taken into account. 30
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