ANGE: Angiopoietin and Adverse Outcomes in Cardiac Surgery

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Recruiting

CT.gov ID

NCT05817929

Collaborator

(none)

300

Enrollment

Location

48.3

Anticipated Duration (Months)

6.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Surgery Acute Kidney Injury	Other: blood sample	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Mar 23, 2023

Anticipated Primary Completion Date :

Apr 1, 2026

Anticipated Study Completion Date :

Apr 1, 2027

Outcome Measures

Primary Outcome Measures

Correlation between abnormal angiopoietin 1 concentration (ng/ml) and number of major cardiovascular event [28 days]
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 [28 days]
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 [28 days]
Correlation between abnormal angiopoietin 2 concentration (ng/ml) and number of postoperative pulmonary complications [28 days]
Correlation between abnormal angiopoietin 1 concentration (ng/ml) and mortality at 3 months [3 months]
Correlation between abnormal angiopoietin 2 concentration (ng/ml) and mortality at 3 months [3 months]
Correlation between abnormal angiopoietin 1 concentration (ng/ml) and mortality at 6 months [6 months]
Correlation between occurence of abnormal angiopoietin 2 concentration (ng/ml) and mortality at 6 months [6 months]
Correlation between abnormal angiopoietin 1 concentration (ng/ml) and mortality rate at 12 months [12 months]
Correlation between abnormal angiopoietin 2 concentration (ng/ml) and mortality rate at 12 months [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Amiens Picardie	Amiens		France

Sponsors and Collaborators

Centre Hospitalier Universitaire, Amiens

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire, Amiens

ClinicalTrials.gov Identifier:

NCT05817929

Other Study ID Numbers:

PI2023_843_0015

First Posted:

Apr 18, 2023

Last Update Posted:

Apr 18, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Centre Hospitalier Universitaire, Amiens

angiopoietin

endothelial injury

MACCE

Additional relevant MeSH terms:

Acute Kidney Injury

Study Results

No Results Posted as of Apr 18, 2023