Biology of Cerebral Arteriovenous Malformations and Prognosis of Cerebral Arteriovenous Malformations

Recruiting

• Conditions: Cerebral Arteriovenous Malformations; Ruptured or Unruptured Cerebral Arteriovenous Malformations

• Registration Number: NCT03676868
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary

The cerebral arteriovenous malformations correspond to the formation of an entanglement of morphologically abnormal vessels called nidus, which shunt the blood circulation directly from the arterial circulation to the venous circulation.

The cerebral arteriovenous malformations are an important cause of hemorrhagic stroke.

The hypothesis is that cerebral haemorrhage associated with a cerebral arteriovenous malformations would come from peri-nidal micro-vessels, in connection with infiltration of leucocytes and / or defective maintenance of microvascular integrity by platelets.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-11
• Study First Submitted QC: 2018-09-17
• Study First Posted: 2018-09-19
• Study Start: 2018-11-20
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-06
• Last Update Posted: 2023-07-07
• Primary Completion: 2028-11-19
• Study Completion: 2028-11-19

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Patient over 18 years old
• Patient with a cerebral AVM for which an intervention (endovascular treatment or surgery) or only clinical monitoring
• Express consent to participate in the study

And

• children
• Free informed and express consent of both holders of the minor patient's parental authority, or, by way of derogation and only if the other holder of parental authority cannot give his or her consent within a time limit compatible with the methodological requirements specific to the conduct of the research with regard to its purposes, of one of the two holders of parental authority

Exclusion Criteria

• Patient benefiting from a legal protection measure
• Pregnant or breast feeding woman

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Associaton between dosage of endothelial marker and the arteriovenous malformation pronostic	6 months	associaton between dosage of endothelial marker in blood samples and correlation with clinical outcome
Associaton between dosage of neutrophilic and the arteriovenous malformation pronostic	6 months	Dosage of neutrophilic in blood samples and correlation with clinical outcome
Associaton between dosage of platelet and the arteriovenous malformation pronostic	6 months	Dosage of platelet in blood samples and correlation with clinical outcome
Associaton between neo-angiogenesis activation markers and the arteriovenous malformation pronostic	6 months	Dosage neo-angiogenesis activation markers in blood samples and correlation with clinical outcome

Trial Locations

Locations (1)

Fondation Ophtalmologique Rotschild; 🇫🇷 Paris, France