Surgery--ComplicationsMAPOVASNCT04679077
Preoperative Microcirculation and Postoperative Outcome After Major Vascular Surgery
A study testing Cytocam-IDF imaging device in people with Surgery--Complications, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery--Complications
- What is being tested?
- Cytocam-IDF imaging device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Feb 2021to 1 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative Microcirculation and Postoperative Outcome After Major Vascular Surgery: a Prospective Cohort Study
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.
- Conditions
- Surgery--Complications
- Being tested
- Cytocam-IDF imaging device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytocam-IDF imaging deviceOther
Observation of the microcirculation
| Study group | Role | What they receive |
|---|---|---|
| Cytocam-IDF Imaging | Other | All patients will undergo the same interventional test. Receives: Other: Cytocam-IDF imaging device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative high-sensitive troponin T (hsTnT)
Indicator of acute coronary syndrome
Measured: 30 days
Secondary outcomes (4)
Cause of death
Causes of death
Measured: 30 days
Non-cardiovascular adverse events and serious adverse events
Incidence of non-cardiovascular complications
Measured: 30 days
Cardiovascular adverse events and serious adverse events
Incidence of cardiovascular complications
Measured: 30 days
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.
Measured: 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start1 Feb 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion1 Feb 2022 (estimated)
Why it stopped: Study was never submitted to the ethics committee
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery--ComplicationsStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04679077
- Sponsor's protocol ID
- MAPOVAS
- Acronym
- MAPOVAS
- Status last verified
- May 2023
- First submitted
- 9 Dec 2020
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Microcirculation and Postoperative Outcome After Major Vascular Surgery: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04679077
- Acronym / sponsor ID
- MAPOVAS / MAPOVAS
- Conditions
- Surgery--Complications
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was never submitted to the ethics committee
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 1 Feb 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 1 Feb 2022 (estimated)
- First posted
- 22 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients will be split into two groups after data collection. They will receive the same treatment during the clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Cytocam-IDF Imaging | Other | Other: Cytocam-IDF imaging deviceAll patients will undergo the same interventional test. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years
Key exclusion criteria (4 listed)
- Emergency surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cytocam-IDF imaging deviceObservation of the microcirculation | Other | Cytocam-IDF Imaging |
Primary outcome
Postoperative high-sensitive troponin T (hsTnT)
Time frame: 30 days
Indicator of acute coronary syndrome
4 secondary outcomes
Cause of death
Time frame: 30 days
Non-cardiovascular adverse events and serious adverse events
Time frame: 30 days
Cardiovascular adverse events and serious adverse events
Time frame: 30 days
Correlation between preoperative microcirculation and postoperative outcome during the hospitalization period.
Time frame: 30
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Individual participant dataSharing planned: Undecided. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cytocam-IDF imaging device in people with Surgery--Complications, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative high-sensitive troponin T (hsTnT) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2023.