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临床试验/NCT07387575
NCT07387575Enrolling By Invitation不适用

Screening for Intracranial Unruptured Aneurysms in First-Degree Relatives of Patients With Aneurysmal Subarachnoid Hemorrhage

University of Novi Sad1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2026年2月1日最近更新:

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
300
试验地点
1
主要终点
Detection of unruptured intracranial aneurysms by magnetic resonance angiography (MRA).

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • First-degree relatives (parents, siblings, or children) of patients diagnosed with aneurysmal subarachnoid hemorrhage (aSAH);
  • Age ≥ 30 years at the time of enrollment, and current cigarette smokers or diagnosed with hypertension (either treated or untreated);
  • Able and willing to undergo magnetic resonance angiography (MRA);
  • 5. Able to provide written informed consent;
  • Sporadic aneurysm subjects must have a confirmed UIAs

排除标准

  • History of intracranial aneurysm rupture or prior subarachnoid hemorrhage;
  • Contraindications to MRI/MRA (e.g., pacemaker, metallic implants, severe claustrophobia) or pregnancy (due to MRI safety considerations);
  • A history of polycystic kidney disease, Marfan's Syndrome, Ehlers Danlos Syndrome, or fibromuscular dysplasia;
  • Unable or unwilling to provide informed consent;
  • Participation in another interventional study that could interfere with outcomes.

研究组 & 干预措施

Study Group

150 individuals that are first-degree relatives of affected patients admitted to study center for aneurysmal stroke and 150 individuals with sporadic UIAs

结局指标

主要结局

Detection of unruptured intracranial aneurysms by magnetic resonance angiography (MRA).

时间窗: 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.

次要结局

  • Correlation of aneurysm presence with risk factors(At the time of screening)
  • Aneurysm size and location(At the time of screening)
  • Prevalence of multiple aneurysms(At the time of screening)
  • Assessment of anatomical variations of cerebral arteries(At the time of screening)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nebojsa Lasica

Medical Doctor

University of Novi Sad

研究点 (1)

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