Defining the Basis of Fibromuscular Dysplasia (FMD)
NCT01967511
Arterial Occlusive Diseases, Cardiovascular Diseases
New York, United States
View Trial DetailsNCT Number: NCT06258109
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.
Interested in participating?
Request Info18 year and older
Female
Observational
Stroke Unit Sanatorio Allende, Córdoba, Argentina
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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)
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)
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)
Time frame: From date of first CeAD until date of latest follow-up assessed up to 35 years
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.
Contact information is provided by the study sponsor or research team.
Sandro K Fischer
CONTACT
Stefan T Engelter, MD
CONTACT
University Hospital, Basel, Switzerland
Other
Long-term Risk of Recurrent Cervical Artery Dissection After Pregnancy (LONG-RECAP Study)
Acronym: LONG-RECAP
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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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