Risk of Recurrent CeAD After Pregnancy (LONG-RECAP)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy Complications; Cervical Artery Dissection

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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Stefan T Engelter, MD; Phone Number: +41 61 326 41 05; Email: stefan.engelter@felixplatter.ch
• Study Contact Backup: Name: Sandro K Fischer; Phone Number: +41 61 328 47 84; Email: sandrokevin.fischer@usb.ch

Study Locations

• Argentina
  • Córdoba, Argentina, X5000BFB
    • Recruiting
    • Stroke Unit Sanatorio Allende
• Austria
  • Tirol
    • Innsbruck, Tirol, Austria, 6020
      • Recruiting
      • Department of Neurology, Medical University of Innsbruck
• Finland
  • Helsinki, Finland
    • Recruiting
    • Helsinki University Central Hospital
• Germany
  • Berlin, Germany, 10117
    • Recruiting
    • Charité Universitätsmedizin, Centrum für Schlaganfallforschung
  • Munich, Germany, 81377
    • Recruiting
    • Neurologische Klinik und Poliklinik, LMU Klinikum Campus Großhadern
• Israel
  • Jerusalem, Israel, 91120
    • Recruiting
    • Hadassah-Hebrew University Medical Center
• Italy
  • Brescia, Italy
    • Recruiting
    • Neurology Clinic, University of Brescia
• Mexico
  • Mexico City, Mexico, 14269
    • Recruiting
    • Stroke Clinic, National Institute of Neurology and Neurosurgery Manuel Velasco Suárez
• Switzerland
  • Basel, Switzerland, 4031
    • Recruiting
    • University Hospital Basel, Stroke Center
    • Principal Investigator: Stefan Engelter, MD
    • Contact: Sandro K Fischer; Phone Number: +41 61 328 47 84; Email: sandrokevin.fischer@usb.ch
    • Contact: Stefan T Engelter, MD; Phone Number: +41 61 326 41 30; Email: stefan.engelter@felixplatter.ch
  • Zurich, Switzerland
    • Recruiting
    • University Hospital Zurich, Stroke Center
• United States
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Recruiting
      • University of Utah
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • Recruiting
      • University of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Female patients aged ≥18 years with prior CeAD.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Women with pregnancy after index CeAD; Women who became pregnant at least once after first index CeAD
Women without pregnancy after index CeAD; Women who did not became pregnant after first index CeAD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Number of participants with death		From date of first CeAD until date of latest follow-up assessed up to 35 years
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

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Stefan T Engelter, MD, University Hospital, Basel, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): December 1, 2024
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: January 11, 2024
• First Submitted That Met QC Criteria: February 5, 2024
• First Posted (Actual): February 14, 2024

Study Record Updates

• Last Update Posted (Estimated): December 13, 2024
• Last Update Submitted That Met QC Criteria: December 12, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Ischemic Stroke; Hemorrhagic Stroke
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications
• Other Study ID Numbers: PB_2016_00547; ko23Engelter2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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