Clinical trial NCT06258109: Risk of Recurrent CeAD After Pregnancy
Official title: Long-term Risk of Recurrent Cervical Artery Dissection After Pregnancy (LONG-RECAP Study)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cervical Artery Dissection
Pregnancy Complications
Keywords: Ischemic Stroke
Hemorrhagic Stroke
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2024-02-14
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Female patients aged ≥18 years with prior CeAD.

Brief 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.

Detailed description: Background: Cervical artery dissection (CeAD) is a leading cause of stroke in women of childbearing age. Among the population with an initial CeAD, about 9% show a recurrence event (a range from 0 to 25% has been reported). Recurrence of CeAD can occur for several years after the initial event. CeAD has been shown to occur in association with pregnancy, and the postpartum period, yet it remains unclear whether pregnancy increases the risk of recurrence or delayed stroke. Previous studies on this subject are either based on small sample sizes or lack long-term data.

Objective: The investigators want to determine whether pregnancy increases the risk of recurrent CeAD and delayed stroke in women with prior CeAD based on long-term data.

Furthermore, it will be investigated whether the mode of delivery affects recurrence and if dissections occurred during a particular phase of a woman's reproductive process. The investigators will also investigate if women actively decided against another pregnancy due to the initial CeAD.

Methods: This study will be a multicenter, exploratory case-control study using pooled individual patient data from several stroke centers. The data will be obtained through review of medical records and patient interviews. The study will include all women with any prior CeAD who have had long-term follow-up (at least 6 months, with no upper limit), including information about pregnancy and recurrence of CeAD.

Primary endpoint is a composite outcome measure which consists of (i) occurrence of recurrent CeAD, (ii) occurrence of ischemic or hemorrhagic stroke, (iii) death. Secondary endpoints are the individual components of the primary endpoint and functional outcome assessed by the modified Ranking scale.

Statistical analysis will be used to determine the odds of the primary and secondary endpoints in women who had subsequent pregnancies compared to those who did not.

Eligibility criteria: 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 outcomes:
measure: Number of participants with composite outcome measure - recurrent CeAD, ischemic stroke, hemorrhagic stroke and/or death
timeFrame: From date of first CeAD until date of latest follow-up assessed up to 35 years
Secondary outcomes:
measure: Number of participants with recurrent cervical artery dissection
timeFrame: From date of first CeAD until date of latest follow-up assessed up to 35 years
measure: Number of participants with new ischemic stroke
timeFrame: From date of first CeAD until date of latest follow-up assessed up to 35 years
measure: Number of participants with new hemorrhagic stroke
timeFrame: From date of first CeAD until date of latest follow-up assessed up to 35 years
measure: Number of participants with death
timeFrame: From date of first CeAD until date of latest follow-up assessed up to 35 years
measure: Functional outcome as assessed by modified Rankin Scale (mRS)
timeFrame: At date of latest, individual follow-up assessed up to 35 years after first CeAD
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Córdoba
country: Argentina
facility: Stroke Unit Sanatorio Allende
city: Innsbruck
country: Austria
facility: Department of Neurology, Medical University of Innsbruck
state: Tirol
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
city: Berlin
country: Germany
facility: Charité Universitätsmedizin, Centrum für Schlaganfallforschung
city: Munich
country: Germany
facility: Neurologische Klinik und Poliklinik, LMU Klinikum Campus Großhadern
city: Jerusalem
country: Israel
facility: Hadassah-Hebrew University Medical Center
city: Brescia
country: Italy
facility: Neurology Clinic, University of Brescia
city: Mexico City
country: Mexico
facility: Stroke Clinic, National Institute of Neurology and Neurosurgery Manuel Velasco Suárez
city: Basel
country: Switzerland
facility: University Hospital Basel, Stroke Center
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Stroke Center
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Stefan T Engelter, MD
role: PRINCIPAL_INVESTIGATOR
References: