Recruiting

Observational Study

Sponsor:

University Hospital, Basel, Switzerland

Code:

NCT06258109

Conditions

Cervical Artery Dissection

Pregnancy Complications

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Cervical Artery Dissection

Pregnancy Complications

Study ID

NCT06258109

Start date

Jan 1, 2023

Status verified date

Dec, 2024

Completion date

Jul 1, 2025

Anticipated

Primary completion date

Dec 1, 2024

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Stefan T Engelter, MD

+41 61 326 41 05stefan.engelter@felixplatter.ch

Sandro K Fischer

+41 61 328 47 84sandrokevin.fischer@usb.ch

Locations

University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908

More Information

Sponsor

University Hospital, Basel, Switzerland

Last update posted

Dec 13, 2024

Last verified

Dec, 2024

Keywords

  • Ischemic Stroke
  • Hemorrhagic Stroke

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University Hospital, Basel, Switzerland on 2024-12-13.