Biology of Cerebral Arteriovenous Malformations and Prognosis of Cerebral Arteriovenous Malformations

Cerebral Arteriovenous Malformations Clinical Trial

— BioMAV  

Official title:

Biology of Cerebral Arteriovenous Malformations : Study of the Link Between Blood Biomarkers and the Haemorrhagic Prognosis of Cerebral Arteriovenous Malformations

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03676868
• Other study ID #: JDS_2018_6
• Status: Recruiting
• Start date: November 20, 2018
• Est. completion date: November 19, 2028

Study information

• Verified date: July 2023
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: Amélie Yavchitz
• Phone: 01 48 63 64 54
• Email: ayavchitz[@]for.paris
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: November 19, 2028
• Est. primary completion date: November 19, 2028
• Gender: All
• Age group: 0 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arteriovenous Malformations
• Cerebral Arteriovenous Malformations
• Congenital Abnormalities
• Hemangioma
• Intracranial Arteriovenous Malformations
• Ruptured or Unruptured Cerebral Arteriovenous Malformations

Locations

Country	Name	City	State
France	Fondation Ophtalmologique Rotschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Associaton between dosage of endothelial marker and the arteriovenous malformation pronostic	associaton between dosage of endothelial marker in blood samples and correlation with clinical outcome	6 months
Primary	Associaton between dosage of platelet and the arteriovenous malformation pronostic	Dosage of platelet in blood samples and correlation with clinical outcome	6 months
Primary	Associaton between dosage of neutrophilic and the arteriovenous malformation pronostic	Dosage of neutrophilic in blood samples and correlation with clinical outcome	6 months
Primary	Associaton between neo-angiogenesis activation markers and the arteriovenous malformation pronostic	Dosage neo-angiogenesis activation markers in blood samples and correlation with clinical outcome	6 months