Risk of Recurrent CeAD After Pregnancy

NCT06258109 | Recruiting

• 1 other identifier: PB_2016_00547; ko23Engelter2
• Study Type: observational
• Target: 1,000
• Locations: 9 countries
• Sites: 12

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

Keywords

Ischemic Stroke; Hemorrhagic Stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Number of participants with recurrent cervical artery dissection

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

• Number of participants with new ischemic stroke

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

• Number of participants with new hemorrhagic stroke

  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)

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

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Female patients aged ≥18 years with prior CeAD.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (12)

University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

University of Virginia

Charlottesville, Virginia, 22908, United States

RECRUITING

Stroke Unit Sanatorio Allende

Córdoba, X5000BFB, Argentina

RECRUITING

Department of Neurology, Medical University of Innsbruck

Innsbruck, Tyrol, 6020, Austria

RECRUITING

Helsinki University Central Hospital

Helsinki, Finland

RECRUITING

Charité Universitätsmedizin, Centrum für Schlaganfallforschung

Berlin, 10117, Germany

RECRUITING

Neurologische Klinik und Poliklinik, LMU Klinikum Campus Großhadern

Munich, 81377, Germany

RECRUITING

Hadassah-Hebrew University Medical Center

Jerusalem, 91120, Israel

RECRUITING

Neurology Clinic, University of Brescia

Brescia, Italy

RECRUITING

Stroke Clinic, National Institute of Neurology and Neurosurgery Manuel Velasco Suárez

Mexico City, 14269, Mexico

RECRUITING

University Hospital Basel, Stroke Center

Basel, 4031, Switzerland

RECRUITING

University Hospital Zurich, Stroke Center

Zurich, Switzerland

RECRUITING

MeSH Terms

Conditions

Pregnancy Complications; Ischemic Stroke; Hemorrhagic Stroke

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Stefan T Engelter, MD

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefan T Engelter, MD

CONTACT

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

Sandro K Fischer

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: February 14, 2024
• Study Start: January 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: July 1, 2025
• Last Updated: December 13, 2024

Record last verified: 2024-12

Locations

ME (1); DE (2); AR (1); IL (1); AU (1); IT (1); CH (2); FI (1); US (2)