Risk of Recurrent CeAD After Pregnancy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversity Hospital, Basel, Switzerland
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
female
prior symptomatic cervical artery dissection (= index CeAD)
at least one long-term follow-up visit (at least 6 months after the initial event)
recurrent dissection
Disqualifiers
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
Trial population
Female patients aged ≥18 years with prior CeAD.
Trial design
Design model
Case-control
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
1,000 Participants
are grouped into 2 trial groupsGroup A: Women with pregnancy after index CeAD
Group B: Women without pregnancy after index CeAD
Trial outcomes
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.
Time frame
From date of first CeAD until date of latest follow-up assessed up to 35 yearsSecondary outcomes
1
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)
Time frame
From date of first CeAD until date of latest follow-up assessed up to 35 years2
Number of participants with new ischemic stroke
assessed by medical history or clinical suspicion with confirmation by cerebrovascular imaging (MRI and/or CT)
Time frame
From date of first CeAD until date of latest follow-up assessed up to 35 years3
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)
Time frame
From date of first CeAD until date of latest follow-up assessed up to 35 years4
Number of participants with death
Time frame
From date of first CeAD until date of latest follow-up assessed up to 35 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov