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Preoperative Microcirculation and Postoperative Outcome After Major Vascular Surgery (MAPOVAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04679077
Recruitment Status : Not yet recruiting
First Posted : December 22, 2020
Last Update Posted : December 22, 2020
Sponsor:
Information provided by (Responsible Party):
Universitair Ziekenhuis Brussel

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Surgery--Complications Other: Cytocam-IDF imaging device Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Patients will be split into two groups after data collection. They will receive the same treatment during the clinical trial.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Preoperative Microcirculation and Postoperative Outcome After Major Vascular Surgery: a Prospective Cohort Study
Estimated Study Start Date : February 1, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : February 1, 2022
Arms and Interventions
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Arm Intervention/treatment
Cytocam-IDF Imaging
All patients will undergo the same interventional test.
 Other: Cytocam-IDF imaging device
Observation of the microcirculation


Outcome Measures
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Primary Outcome Measures :
  1. Postoperative high-sensitive troponin T (hsTnT) [ Time Frame: 30 days ]
    Indicator of acute coronary syndrome


Secondary Outcome Measures :
  1. Cause of death [ Time Frame: 30 days ]
    Causes of death

  2. Non-cardiovascular adverse events and serious adverse events [ Time Frame: 30 days ]
    Incidence of non-cardiovascular complications

  3. Cardiovascular adverse events and serious adverse events [ Time Frame: 30 days ]
    Incidence of cardiovascular complications

  4. Correlation between preoperative microcirculation and postoperative outcome during the hospitalization period. [ Time Frame: 30 ]
    In addition, demographic parameters (age, weight, height) and comorbidities will be taken into account.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04679077


Contacts
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Contact: Evelien Vandeurzen, Master 024749237 evelien.vandeurzen@uzbrussel.be

Locations
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Belgium
UZ Brussel
Jette, Brussel, Belgium, 1090
Contact: Evelien Vandeurzen, Master    024749237    evelien.vandeurzen@uzbrussel.be   
Principal Investigator: Hélène De Cuyper, MD         
Sub-Investigator: Jan Poelaert, MD, PhD         
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
More Information
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Responsible Party: Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT04679077    
Other Study ID Numbers: MAPOVAS
First Posted: December 22, 2020    Key Record Dates
Last Update Posted: December 22, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Presentations of both the study protocol and the study results will be held at conferences.

After completion of the study and analysis of the data results will be made publicly without re striction, independent of the outcome. They will be submitted for publication to an international peer-reviewed journal.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No