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NCT Number: NCT06258109

Risk of Recurrent CeAD After Pregnancy

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Stroke Unit Sanatorio Allende, Córdoba, Argentina

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of participants with composite outcome measure - recurrent CeAD, ischemic stroke, hemorrhagic stroke and/or death

    Time frame: 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.

Secondary outcomes

  1. Number of participants with recurrent cervical artery dissection

    Time frame: From date of first CeAD until date of latest follow-up assessed up to 35 years

    assessed by medical history or clinical suspicion with confirmation by cerebrovascular imaging (MRI, MRI angiography, CT, CT angiography, digital subtraction angiography and/or ultrasound)

  2. Number of participants with new ischemic stroke

    Time frame: From date of first CeAD until date of latest follow-up assessed up to 35 years

    assessed by medical history or clinical suspicion with confirmation by cerebrovascular imaging (MRI and/or CT)

  3. Number of participants with new hemorrhagic stroke

    Time frame: From date of first CeAD until date of latest follow-up assessed up to 35 years

    Intracerebral hemorrhage or subarachnoid hemorrhage assessed by medical history or clinical suspicion with confirmation by cerebrovascular imaging (MRI and/or CT)

  4. Number of participants with death

    Time frame: From date of first CeAD until date of latest follow-up assessed up to 35 years

  5. Functional outcome as assessed by modified Rankin Scale (mRS)

    Time frame: At date of latest, individual follow-up assessed up to 35 years after first CeAD

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sandro K Fischer

CONTACT

[email protected]

+41 61 328 47 84

Stefan T Engelter, MD

CONTACT

[email protected]

+41 61 326 41 05

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Acronym: LONG-RECAP

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Feb 14, 2024
Registry last updated
Dec 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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