Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06258109
Status:
RECRUITING
Last Update Posted:
2024-02-14
First Post:
2024-01-11
Brief Title:
Risk of Recurrent CeAD After Pregnancy
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
Long-term Risk of Recurrent Cervical Artery Dissection After Pregnancy LONG-RECAP Study
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LONG-RECAP
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
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
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 womans 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
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 womans 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None