Biology of Cerebral Arteriovenous Malformations and Prognosis of Cerebral Arteriovenous Malformations (BioMAV)

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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Amélie Yavchitz; Phone Number: +33 01 48 63 64 54; Email: ayavchitz@for.paris
• Study Contact Backup: Name: Jean Philippe DESILLES; Email: jp.desilles@for.paris

Study Locations

• France
  • Paris, France, 75019
    • Recruiting
    • Fondation Ophtalmologique Rotschild
    • Contact: Dr Jean-Philippe DESILLES; Email: jpdesilles@for.paris

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Patient with a cerebral arterioveinus malformation for which an intervention (endovascular treatment or surgery) or only clinical monitoring is planned

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Associaton between dosage of platelet and the arteriovenous malformation pronostic	Dosage of platelet in blood samples and correlation with clinical outcome	6 months
Associaton between dosage of neutrophilic and the arteriovenous malformation pronostic	Dosage of neutrophilic in blood samples and correlation with clinical outcome	6 months
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

Collaborators and Investigators

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2018
• Primary Completion (Estimated): November 19, 2028
• Study Completion (Estimated): November 19, 2028

Study Registration Dates

• First Submitted: September 11, 2018
• First Submitted That Met QC Criteria: September 17, 2018
• First Posted (Actual): September 19, 2018

Study Record Updates

• Last Update Posted (Actual): July 7, 2023
• Last Update Submitted That Met QC Criteria: July 6, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Cardiovascular Abnormalities; Neoplasms, Vascular Tissue; Nervous System Malformations; Vascular Malformations; Intracranial Arterial Diseases; Central Nervous System Vascular Malformations; Congenital Abnormalities; Hemangioma; Arteriovenous Malformations; Intracranial Arteriovenous Malformations
• Other Study ID Numbers: JDS_2018_6

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No