Hereditary Hemorrhagic Telangiectasia (HHT) and Its Diverse Neurological Manifestations: Unraveling the Intricacies of an Enigmatic Disorder
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Number of new patients with Cerebral Arteriovenous malformation
研究概览
简要总结
With a described prevalence of brain arteriovenous malformations (CAVM) of 12.8% in HHT patients, of whom 10% presents with intracranial hemorrhage, HHT pose a risk of devastating intracranial hemorrhage.
The main objective of the study is to challenge current statements (pros and cons) regarding systematic screening of asymptomatic HHT patients for neurovascular manifestations.
The investigators are thus seeking to answer a question many screening programs have faced.
A screening program should screen for a manageable problem, by a method that is considered cost effective and does not cause negative effect, even when extrapolated to a large cohort. Finally, the positive effect of screening program should outweigh the negative and not cause unnecessary concerns for the patients. The investigators are seeking to draw perspectives from the results to general questions about screening programs.
详细描述
The Investigators are conducting a study investigating the disease, Hereditary Hemorrhagic Telangiectasia (HHT) and its neuro-logical and -vascular manifestations.
With a described prevalence of brain arteriovenous malformations (CAVM) of 12.8% in HHT patients, of whom 10% presents with intracranial hemorrhage, HHT pose a risk of devastating intracranial hemorrhage.
The main objective of the study is to challenge current statements (pros and cons) regarding systematic screening of asymptomatic HHT patients for neurovascular manifestations.
The investigators seek to fulfill the objective by offering all Danish HHT patients between 18-65 years of age, an MRI of the brain. Participants are asked to answer two questionnaires (SF-36 and BDI II) before and after the MRI. 100 participants are offered an MRI ASL in order, to investigate if this MRI sequence is more suitable to seek out vascular malformations of the brain.
The study is being performed at the University Hospital of Odense; participants receive their MRI at the radiological center closest to their home address. All participants are included, informed, and briefly interviewed over the telephone. Participants will be recruited using the Danish HHT database.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HHT according to the clinical diagnostic criteria (curacao)
- •18-65 years of age.
- •registered in the Danish HHT-database
排除标准
- •patients has received an MRI of the brain with angio sequences, within the last 5 years.
- •contraindications to MRI
- •contraindications to self-reported questionnaires (i.e. mental retardation)
结局指标
主要结局
Number of new patients with Cerebral Arteriovenous malformation
时间窗: 1st of April 2022 - 30th of June 2025.
MRI verified arteriovenous malformation
次要结局
- Number of new patients with Ischemic stroke(1st of April 2022 - 30th of June 2025.)
- Becks Depression Inventory II(Baseline - inclusion, and 3 months after screening with MRI, and (in case of treatment) 3 months after treatment. 1st of April 2022 - 30th of June 2025.)
- Number of new patients with Hemorrhagic stroke(1st of April 2022 - 30th of June 2025.)
- MRI arterial spin labeling (ASL)(1st of April 2022 - 30th of June 2025.)
- Short Form 26(Baseline - inclusion, and 3 months after screening with MRI, and (in case of treatment) 3 months after treatment. 1st of April 2022 - 30th of June 2025.)