Cardiac SurgeryANGENCT05817929
Angiopoietin and Adverse Outcomes in Cardiac Surgery
A study testing blood sample in people with Cardiac Surgery and Acute Kidney Injury, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery, Acute Kidney Injury
- What is being tested?
- blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 23 Mar 2023to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patient scheduled for cardiac surgery under cardiopulmonary bypass
Who cannot join
- patient less than 18 years old,
- redo surgery,
- urgent surgery,
- endocarditis,
- aortic root repair surgery
- aortic dissection
- heart beating surgery,
- heart transplantation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Amiens Picardie
Amiens
Osama ABOU ARAB, 03 22 08 78 36, abouarab.osama@chu-amiens.fr
About this study
Official title: Angiopoietin Dysregulation to Predict Adverse Outcomes in Cardiac Surgery: the Prospective
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.
- Conditions
- Cardiac Surgery, Acute Kidney Injury
- Being tested
- blood sample
- Keywords
- angiopoietin, endothelial injury, MACCE
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleOther
5 ml blood sample will be withdrawn at the surgery start and at the surgery end
| Study group | Role | What they receive |
|---|---|---|
| cardiac surgery | Experimental | Not described Receives: Other: blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 28 days
Secondary outcomes (8)
Correlation between abnormal angiopoietin 1 concentration (ng/ml) and number of postoperative pulmonary complications
Measured: 28 days
Correlation between abnormal angiopoietin 2 concentration (ng/ml) and number of postoperative pulmonary complications
Measured: 28 days
Correlation between abnormal angiopoietin 1 concentration (ng/ml) and mortality at 3 months
Measured: 3 months
Correlation between abnormal angiopoietin 2 concentration (ng/ml) and mortality at 3 months
Measured: 3 months
Correlation between abnormal angiopoietin 1 concentration (ng/ml) and mortality at 6 months
Measured: 6 months
Correlation between occurence of abnormal angiopoietin 2 concentration (ng/ml) and mortality at 6 months
Measured: 6 months
Correlation between abnormal angiopoietin 1 concentration (ng/ml) and mortality rate at 12 months
Measured: 12 months
Correlation between abnormal angiopoietin 2 concentration (ng/ml) and mortality rate at 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start23 Mar 2023
- Primary completionApr 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05817929
- Sponsor's protocol ID
- PI2023_843_0015
- Acronym
- ANGE
- Status last verified
- May 2025
- First submitted
- 23 Mar 2023
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Angiopoietin Dysregulation to Predict Adverse Outcomes in Cardiac Surgery: the Prospective
- ClinicalTrials.gov ID
- NCT05817929
- Acronym / sponsor ID
- ANGE / PI2023_843_0015
- Conditions
- Cardiac Surgery, Acute Kidney Injury
- Keywords
- angiopoietin, endothelial injury, MACCE
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 23 Mar 2023 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cardiac surgery | Experimental | Other: blood sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patient scheduled for cardiac surgery under cardiopulmonary bypass
Key exclusion criteria (8 listed)
- patient less than 18 years old,
- redo surgery,
- urgent surgery,
- endocarditis,
- aortic root repair surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood sample5 ml blood sample will be withdrawn at the surgery start and at the surgery end | Other | cardiac surgery |
Primary outcome
Correlation between abnormal angiopoietin 1 concentration (ng/ml) and number of major cardiovascular event
Time frame: 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
Time frame: 28 days
major cardiovascular event are myocardial infraction, stroke, acute kidney injury, cardiovascular death
8 secondary outcomes
Correlation between abnormal angiopoietin 1 concentration (ng/ml) and number of postoperative pulmonary complications
Time frame: 28 days
Correlation between abnormal angiopoietin 2 concentration (ng/ml) and number of postoperative pulmonary complications
Time frame: 28 days
Correlation between abnormal angiopoietin 1 concentration (ng/ml) and mortality at 3 months
Time frame: 3 months
Correlation between abnormal angiopoietin 2 concentration (ng/ml) and mortality at 3 months
Time frame: 3 months
Correlation between abnormal angiopoietin 1 concentration (ng/ml) and mortality at 6 months
Time frame: 6 months
Correlation between occurence of abnormal angiopoietin 2 concentration (ng/ml) and mortality at 6 months
Time frame: 6 months
Correlation between abnormal angiopoietin 1 concentration (ng/ml) and mortality rate at 12 months
Time frame: 12 months
Correlation between abnormal angiopoietin 2 concentration (ng/ml) and mortality rate at 12 months
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sample in people with Cardiac Surgery and Acute Kidney Injury, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Osama ABOU ARAB, MD (03 22 08 78 36, abouarab.osama@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between abnormal angiopoietin 1 concentration (ng/ml) and number of major cardiovascular event (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.