University Clinical Center of Vojvodina
Novi Sad, Vojvodina, 21137, Serbia
NCT Number: NCT07387575
The purpose of this study is to screen first-degree relatives of patients with aneurysmal subarachnoid hemorrhage using magnetic resonance angiography to detect unruptured intracranial aneurysms. This study aims to identify individuals who are at increased risk and determine the effect of environmental factors for development of unruptured intracranial aneurysms.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Novi Sad, Vojvodina, 21137, Serbia
The prevalence of intracranial aneurysms is 3-5% according to studies, while the annual incidence of complications in the form of bleeding from an intracranial aneurysm is 8-10 per 100 000 people. Subarachnoid hemorrhage is an urgent condition characterized by the extravasation of blood into the space surrounding the central nervous system, which is filled with cerebrospinal fluid. The leading cause of non-traumatic subarachnoid hemorrhage is the rupture of an intracranial aneurysm, accounting for approximately 80-85% of cases, and it is associated with a high rate of complications and mortality. Therefore, early detection of patients at elevated risk, monitoring, and management of unruptured intracranial aneurysms is of paramount importance.
Data suggest that first-degree relatives of a family member affected have higher risk for developing intracranial aneurysm. Screening in Relatives with Elevated Risk for Unruptured Intracranial Aneurysms is research effort of neurosurgeons and neuroradiologists to identify environmental factors in study population of Vojvodina (Serbia), that contribute to development of intracranial aneurysms. This study will involve at least 150 siblings (first-degree relatives) of patients who suffered aneurysmal stroke, and determine effect of demographics, environmental factors including, smoking, medical comorbidities and hypertension, caffeinated drink consumption, and hard physical work on the development of unruptured intracranial aneurysms (UIAs). This study of affected families and individuals, known as Screening in Relatives with Elevated Risk for Unruptured Intracranial Aneurysms (SIREN) study, is sponsored by Provincial Secretariat of Health of the Autonomous Province of Vojvodina (Special Screening Program).
This study will also involve at least 150 individuals with no past family history of aneurysmal stroke or UIAs. SIREN study will take part in Autonomous Province in Vojvodina only.
In order to be eligible for the study, individuals with affected family member that was admitted to study center for aneurysmal stroke, had to be older than 30 years of age, and first-degree relatives (father, mother, sister, brother, daughter, or son).
Participants will be asked to complete informed consent and questionnaire with past medical and family history. After completing questionnaires, their arterial blood pressure will be measured. Participants will receive no monetary compensation for participation.
Identification of demographic and environmental risk factors contributing to development of UIAs in families of affected individuals may result in early detection of ones at risk and potentially prevent formation of UIAs or complications including aneurysmal stroke.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: At the time of screening (single MRA examination)
The proportion of screened first-degree relatives (aged ≥30) who are found to have one or more UIAs.
Time frame: At the time of screening
Analysis of the association between demographic and environmental (e.g., age, ethnicity, cigarette smoking, hypertension, consumption of caffeinated drinks, etc.) and the presence of UIAs.
Time frame: At the time of screening
Characterization of detected aneurysms by maximal size (millimeters) and anatomical location within the cerebral vasculature.
Time frame: At the time of screening
Proportion of participants with multiple intracranial aneurysms (MIAs) detected on MRA. MIAs are defined as more than one UIAs in one patient.
Time frame: At the time of screening
Identification and classification of anatomical variations (e.g., vessel hypoplasia, fenestrations, duplicated arteries, circle of Willis variations, etc.) and evaluation of their association with the presence of UIAs.
University of Novi Sad
Other
Screening for Intracranial Unruptured Aneurysms in First-Degree Relatives of Patients With Aneurysmal Subarachnoid Hemorrhage
Acronym: SIREN
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
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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