Investigating the risk of recurrent cervical artery dissection after pregnancy

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

This study is trying to see if having a baby increases the chances of women who have had cervical artery dissection getting it again or having a stroke.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: University Hospital, Basel, Switzerland (Academic / other)
• Locations: 12 sites (Salt Lake City, Utah and 11 other locations)
• Trial ID: NCT06258109 on ClinicalTrials.gov

What this trial studies

This observational study aims to determine if pregnancy increases the risk of recurrent cervical artery dissection (CeAD) and delayed stroke in women who have previously experienced CeAD. It will utilize pooled individual patient data from multiple stroke centers, focusing on long-term follow-up of women with prior CeAD. The primary endpoint includes the occurrence of recurrent CeAD, ischemic or hemorrhagic stroke, and death. The study will also explore the impact of delivery mode on recurrence and whether women chose to avoid pregnancy due to their initial CeAD.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 and older who have a history of symptomatic cervical artery dissection and have undergone long-term follow-up.

Not a fit: Patients who are male or under 18 years old, or those without long-term follow-up data will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide critical insights into the risks associated with pregnancy for women with a history of cervical artery dissection.

How similar studies have performed: Previous studies on this topic have been limited by small sample sizes and lack of long-term data, making this approach relatively novel.

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

Where this trial is running

Salt Lake City, Utah and 11 other locations

• University of Utah — Salt Lake City, Utah, United States (Recruiting)
• University of Virginia — Charlottesville, Virginia, United States (Recruiting)
• Stroke Unit Sanatorio Allende — Córdoba, Argentina (Recruiting)
• Department of Neurology, Medical University of Innsbruck — Innsbruck, Tyrol, Austria (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)

Study contacts

• Principal investigator: Stefan T Engelter, MD — University Hospital, Basel, Switzerland
• Study coordinator: Stefan T Engelter, MD

Conditions Cervical Artery Dissection; Pregnancy Complications; Ischemic Stroke; Hemorrhagic Stroke