Risk of Recurrent CeAD After Pregnancy

NCT06258109 · tracked via the Priya Life Science Italy tracker

Sponsor

University Hospital, Basel, Switzerland

Phase

Observational

Started

2023-01-01

Last updated

2024-12-13

Condition(s) studied

Cervical Artery DissectionPregnancy Complications

Study summary

Primary objective: To determine whether pregnancy increases the risk of recurrent CeAD and delayed stroke in women with prior CeAD based on long-term data.

Methods: Multicentric, observational case-control study based on pooled individual patient data from several stroke centers.

Primary endpoint: Primary composite outcome measure includes the following outcomes: (i) occurrence of recurrent CeAD, (ii) occurrence of ischemic or hemorrhagic stroke, (iii) death.

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * female * prior symptomatic cervical artery dissection (= index CeAD) * at least one long-term follow-up visit (at least 6 months after the initial event) * with information available on outcome events: * recurrent dissection * ischemic stroke * hemorrhagic stroke * functional outcome assessed by mRS score * with data on pregnancy after the initial event * at least 18 years old at the initial event Exclusion Criteria: * Male patients * Age \<18 years * No long-term follow-up available or long-term follow-up \< 6 months after initial event * No data on pregnancy after initial event available

Primary outcome measure(s)

Number of participants with composite outcome measure - recurrent CeAD, ischemic stroke, hemorrhagic stroke and/or death — From date of first CeAD until date of latest follow-up assessed up to 35 years
The composite outcome measure includes the following outcome measures during the follow-up: (i) occurence of recurrent cervical artery dissection (CeAD), (ii) occurrence of any ischemic stroke, (iii) occurrence of any hemorrhagic stroke, (iv) death.

Trial sites (12)

Facility	City	Region	Status
University of Utah	Salt Lake City	Utah	Recruiting
University of Virginia	Charlottesville	Virginia	Recruiting
Stroke Unit Sanatorio Allende	Córdoba	Argentina	Recruiting
Department of Neurology, Medical University of Innsbruck	Innsbruck	Tyrol	Recruiting
Helsinki University Central Hospital	Helsinki	Finland	Recruiting
Charité Universitätsmedizin, Centrum für Schlaganfallforschung	Berlin	Germany	Recruiting
Neurologische Klinik und Poliklinik, LMU Klinikum Campus Großhadern	Munich	Germany	Recruiting
Hadassah-Hebrew University Medical Center	Jerusalem	Israel	Recruiting
Neurology Clinic, University of Brescia	Brescia	Italy	Recruiting
Stroke Clinic, National Institute of Neurology and Neurosurgery Manuel Velasco Suárez	Mexico City	Mexico	Recruiting
University Hospital Basel, Stroke Center	Basel	Switzerland	Recruiting
University Hospital Zurich, Stroke Center	Zurich	Switzerland	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06258109 on ClinicalTrials.gov ↗ ← All trials in Italy