Angiopoietin and Adverse Outcomes in Cardiac Surgery (ANGE)
Primary Purpose
Cardiac Surgery, Acute Kidney Injury
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood sample
Sponsored by
About this trial
This is an interventional other trial for Cardiac Surgery focused on measuring angiopoietin, endothelial injury, MACCE
Eligibility Criteria
Inclusion Criteria: adult patient scheduled for cardiac surgery under cardiopulmonary bypass Exclusion Criteria: patient less than 18 years old, redo surgery, urgent surgery, endocarditis, aortic root repair surgery aortic dissection heart beating surgery, heart transplantation
Sites / Locations
- CHU Amiens PicardieRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
cardiac surgery
Arm Description
Outcomes
Primary Outcome Measures
Correlation between abnormal angiopoietin 1 concentration (ng/ml) and number of major cardiovascular event
major cardiovascular event are myocardial infraction, stroke, acute kidney injury, cardiovascular death
correlation between occurence of abnormal angiopoietin 2 concentration (ng/ml) and occurence of major cardiovascular event
major cardiovascular event are myocardial infraction, stroke, acute kidney injury, cardiovascular death
Secondary Outcome Measures
Correlation between abnormal angiopoietin 1 concentration (ng/ml) and number of postoperative pulmonary complications
Correlation between abnormal angiopoietin 2 concentration (ng/ml) and number of postoperative pulmonary complications
Correlation between abnormal angiopoietin 1 concentration (ng/ml) and mortality at 3 months
Correlation between abnormal angiopoietin 2 concentration (ng/ml) and mortality at 3 months
Correlation between abnormal angiopoietin 1 concentration (ng/ml) and mortality at 6 months
Correlation between occurence of abnormal angiopoietin 2 concentration (ng/ml) and mortality at 6 months
Correlation between abnormal angiopoietin 1 concentration (ng/ml) and mortality rate at 12 months
Correlation between abnormal angiopoietin 2 concentration (ng/ml) and mortality rate at 12 months
Full Information
NCT ID
NCT05817929
First Posted
March 23, 2023
Last Updated
April 25, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT05817929
Brief Title
Angiopoietin and Adverse Outcomes in Cardiac Surgery
Acronym
ANGE
Official Title
Angiopoietin Dysregulation to Predict Adverse Outcomes in Cardiac Surgery: the Prospective
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 23, 2023 (Actual)
Primary Completion Date
April 2026 (Anticipated)
Study Completion Date
April 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Cardiac surgery and cardiopulmonary bypass can lead to systemic organ failure trough excess inflammation and endothelial injury. The angiopoietin family represented by angiopoietin 1 and 2 can reflect endothelial injury by a decrease in angiopoietin 1 and an increase in angiopoietin 2. The investigators hypothesized that angiopoietin dysregulation could reflect organ failure related to cardiac surgery.
The purpose of this project is to assess the association between angiopoietin dysregulation and adverse outcomes on cardiac surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Surgery, Acute Kidney Injury
Keywords
angiopoietin, endothelial injury, MACCE
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
cardiac surgery
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
blood sample
Intervention Description
5 ml blood sample will be withdrawn at the surgery start and at the surgery end
Primary Outcome Measure Information:
Title
Correlation between abnormal angiopoietin 1 concentration (ng/ml) and number of major cardiovascular event
Description
major cardiovascular event are myocardial infraction, stroke, acute kidney injury, cardiovascular death
Time Frame
28 days
Title
correlation between occurence of abnormal angiopoietin 2 concentration (ng/ml) and occurence of major cardiovascular event
Description
major cardiovascular event are myocardial infraction, stroke, acute kidney injury, cardiovascular death
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Correlation between abnormal angiopoietin 1 concentration (ng/ml) and number of postoperative pulmonary complications
Time Frame
28 days
Title
Correlation between abnormal angiopoietin 2 concentration (ng/ml) and number of postoperative pulmonary complications
Time Frame
28 days
Title
Correlation between abnormal angiopoietin 1 concentration (ng/ml) and mortality at 3 months
Time Frame
3 months
Title
Correlation between abnormal angiopoietin 2 concentration (ng/ml) and mortality at 3 months
Time Frame
3 months
Title
Correlation between abnormal angiopoietin 1 concentration (ng/ml) and mortality at 6 months
Time Frame
6 months
Title
Correlation between occurence of abnormal angiopoietin 2 concentration (ng/ml) and mortality at 6 months
Time Frame
6 months
Title
Correlation between abnormal angiopoietin 1 concentration (ng/ml) and mortality rate at 12 months
Time Frame
12 months
Title
Correlation between abnormal angiopoietin 2 concentration (ng/ml) and mortality rate at 12 months
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult patient scheduled for cardiac surgery under cardiopulmonary bypass
Exclusion Criteria:
patient less than 18 years old,
redo surgery,
urgent surgery,
endocarditis,
aortic root repair surgery
aortic dissection
heart beating surgery,
heart transplantation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Osama ABOU ARAB, MD
Phone
03 22 08 78 36
Email
abouarab.osama@chu-amiens.fr
Facility Information:
Facility Name
CHU Amiens Picardie
City
Amiens
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Osama ABOU ARAB
Phone
03 22 08 78 36
Email
abouarab.osama@chu-amiens.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Angiopoietin and Adverse Outcomes in Cardiac Surgery
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