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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
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cardiac Surgery focused on measuring angiopoietin, endothelial injury, MACCE

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
March 23, 2023
Last Updated
April 25, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
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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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