NCT05817929

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
10mo left

Started Mar 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Mar 2023Apr 2027

First Submitted

Initial submission to the registry

March 23, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

March 23, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Expected
Last Updated

May 25, 2025

Status Verified

May 1, 2025

Enrollment Period

3 years

First QC Date

March 23, 2023

Last Update Submit

May 21, 2025

Conditions

Keywords

angiopoietinendothelial injuryMACCE

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (1)

cardiac surgery

EXPERIMENTAL
Other: blood sample

Interventions

5 ml blood sample will be withdrawn at the surgery start and at the surgery end

cardiac surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patient scheduled for cardiac surgery under cardiopulmonary bypass

You may not qualify if:

  • patient less than 18 years old,
  • redo surgery,
  • urgent surgery,
  • endocarditis,
  • aortic root repair surgery
  • aortic dissection
  • heart beating surgery,
  • heart transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens Picardie

Amiens, France

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2023

First Posted

April 18, 2023

Study Start

March 23, 2023

Primary Completion

April 1, 2026

Study Completion (Estimated)

April 1, 2027

Last Updated

May 25, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations