Risk of Recurrent CeAD After Pregnancy

Pregnancy Complications Clinical Trial

— LONG-RECAP  

Official title:

Long-term Risk of Recurrent Cervical Artery Dissection After Pregnancy (LONG-RECAP Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06258109
• Other study ID #: PB_2016_00547; ko23Engelter2
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: University Hospital, Basel, Switzerland
• Contact: Stefan T Engelter, MD
• Phone: +41 61 326 41 05
• Email: stefan.engelter[@]felixplatter.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Artery Dissection
• Pregnancy Complications

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Countries where clinical trial is conducted

United States,  Argentina,  Austria,  Finland,  Germany,  Israel,  Italy,  Mexico,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with composite outcome measure - recurrent CeAD, ischemic stroke, hemorrhagic stroke and/or death	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.	From date of first CeAD until date of latest follow-up assessed up to 35 years
Secondary	Number of participants with recurrent cervical artery dissection	assessed by medical history or clinical suspicion with confirmation by cerebrovascular imaging (MRI, MRI angiography, CT, CT angiography, digital subtraction angiography and/or ultrasound)	From date of first CeAD until date of latest follow-up assessed up to 35 years
Secondary	Number of participants with new ischemic stroke	assessed by medical history or clinical suspicion with confirmation by cerebrovascular imaging (MRI and/or CT)	From date of first CeAD until date of latest follow-up assessed up to 35 years
Secondary	Number of participants with new hemorrhagic stroke	Intracerebral hemorrhage or subarachnoid hemorrhage assessed by medical history or clinical suspicion with confirmation by cerebrovascular imaging (MRI and/or CT)	From date of first CeAD until date of latest follow-up assessed up to 35 years
Secondary	Number of participants with death		From date of first CeAD until date of latest follow-up assessed up to 35 years
Secondary	Functional outcome as assessed by modified Rankin Scale (mRS)	The scale runs from 0-6, running from perfect health without symptoms to death.; 0 - No symptoms.; - No significant disability. Able to carry out all usual activities, despite some symptoms.; - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.; - Moderate disability. Requires some help, but able to walk unassisted.; - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.; - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.; - Dead.	At date of latest, individual follow-up assessed up to 35 years after first CeAD