Angiopoietin and Adverse Outcomes in Cardiac Surgery

Acute Kidney Injury Clinical Trial

— ANGE  

Official title:

Angiopoietin Dysregulation to Predict Adverse Outcomes in Cardiac Surgery: the Prospective

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05817929
• Other study ID #: PI2023_843_0015
• Status: Recruiting
• Phase: N/A
• Start date: March 23, 2023
• Est. completion date: April 2027

Study information

• Verified date: March 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Osama ABOU ARAB, MD
• Phone: 03 22 08 78 36
• Email: abouarab.osama[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: April 2027
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Cardiac Surgery

Intervention

Other:
• blood sample
5 ml blood sample will be withdrawn at the surgery start and at the surgery end

Locations

Country	Name	City	State
France	CHU Amiens Picardie	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	28 days
Primary	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	28 days
Secondary	Correlation between abnormal angiopoietin 1 concentration (ng/ml) and number of postoperative pulmonary complications		28 days
Secondary	Correlation between abnormal angiopoietin 2 concentration (ng/ml) and number of postoperative pulmonary complications		28 days
Secondary	Correlation between abnormal angiopoietin 1 concentration (ng/ml) and mortality at 3 months		3 months
Secondary	Correlation between abnormal angiopoietin 2 concentration (ng/ml) and mortality at 3 months		3 months
Secondary	Correlation between abnormal angiopoietin 1 concentration (ng/ml) and mortality at 6 months		6 months
Secondary	Correlation between occurence of abnormal angiopoietin 2 concentration (ng/ml) and mortality at 6 months		6 months
Secondary	Correlation between abnormal angiopoietin 1 concentration (ng/ml) and mortality rate at 12 months		12 months
Secondary	Correlation between abnormal angiopoietin 2 concentration (ng/ml) and mortality rate at 12 months		12 months