International Headache and Vertigo Registration Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200,000
- 试验地点
- 1
- 主要终点
- Moderate / Severe Headache Days
研究概览
简要总结
In the International Headache and Vertigo Registration Study, patients aged 4-99 years with headache (primary headache and secondary headache such as migraine and tension type headache), vertigo (vertigo diseases such as vestibular migraine) and chronic pain (fibromyalgia and other diseases) were collected. The biomarkers, imaging features, right-to-left shunt of the heart (lung), genetic characteristics, treatment, and outcome (in relation to other diseases) of headache-related diseases were studied, and long-term follow-up was planned.
详细描述
- Research contents:
In the International Headache and Vertigo Registration Study, patients aged 4-99 years with headache (primary headache and secondary headache such as migraine and tension type headache), vertigo (vertigo diseases such as vestibular migraine) and chronic pain (fibromyalgia and other diseases) were collected. The biomarkers, imaging features, right-to-left shunt of the heart (lung), genetic characteristics, treatment, and outcome (in relation to other diseases) of headache-related diseases were studied, and long-term follow-up was planned. 2. Research target:
We study biomarkers, imaging features, right-to-left shunt of heart (lung), genetic features, real-world treatment studies, and outcomes (in relation to other diseases) for headache and vertigo related diseases.
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
- 4 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The following are requirements for entry into the study:
- •Written informed consent and participant privacy information (eg, Written Authorization for Use and Release of Health and Research Study Information) obtained from the participant prior to initiation of any study-specific procedures.
- •Male or female participants ages 4 to 99 years, inclusive, at Visit
- •Headache patients meeting the diagnostic criteria for ICHD-3, including primary headaches such as migraine and tension tension-type headaches, secondary headaches, and patients who meet the headache diagnosis in the ICHD-3 appendix (including vestibular migraine).
排除标准
- •Patients who were unable to complete scales such as headache diary.
- •Patients denied or unable to be admitted for long-term follow-up.
结局指标
主要结局
Moderate / Severe Headache Days
时间窗: Medium term: within 6 months after initial diagnosis; long term: 60 years
Moderate / severe headache days are defined as a day in which moderate or severe pain persists for at least 4 hours, or headache lasts for one day after successful medication for acute headache. These definitions allow the use of relatively simple headache diaries. Subjects were required to indicate whether headache was present (yes / no), peak (mild / moderate / severe) severity and duration (\< 4h or 4h), type of acute drug intake (triptan ergot / other), and response to treatment should also be recorded.
Migraine Attack
时间窗: Medium term: within 6 months after initial diagnosis; long term: 60 years
Migraine attack is defined as any consistent migraine attacks or the use of specific migraine drugs. If a migraine attack is interrupted by sleep, or temporarily relieved, and then relapses within 48 hours, it is considered an attack. In addition, migraine attacks that were successfully treated with drugs but relapsed within 48 hours and lasted for more than 48 hours were counted as one attack.
Days of Migraine
时间窗: Medium term: within 6 months after initial diagnosis; long term: 60 years
The number of days of migraine is the number of days in which migraine occurs or is likely to be migraine (according to IHS ICHD-3 diagnostic criteria). A migraine day is a day when a headache lasts for more than 30 minutes, does not take painkillers, and meets the ICHD-3 migraine or most likely migraine criteria. Migraine day can also be defined as a headache day that is effective for the acute treatment of specific migraine drugs (triptan, ditan, gepant, ergotamine, etc.).
次要结局
- Days Without Headache(Medium term: within 6 months after initial diagnosis; long term: 60 years)
- Headache Impact Scale (HIT-6)(Medium term: within 6 months after initial diagnosis; long term: 60 years)
- Euroqol-5 Dimension Questionnaire (EQ-5D)(Medium term: within 6 months after initial diagnosis; long term: 60 years)
- Blood Pressure(Medium term: within 6 months after initial diagnosis; long term: 60 years)
- Headache Intensity(Medium term: within 6 months after initial diagnosis; long term: 60 years)
- Cumulative Hours of Moderate / Severe Pain at 28 Days(Medium term: within 6 months after initial diagnosis; long term: 60 years)
- Migraine Disability Assessment (MIDAS)(Medium term: within 6 months after initial diagnosis; long term: 60 years)
- Generalized Anxiety Disorder (GAD-7)(Medium term: within 6 months after initial diagnosis; long term: 60 years)
- Peak Headache Pain Intensity(Medium term: within 6 months after initial diagnosis; long term: 60 years)
- Arterial spin labeling(ASL) in MRI(Medium term: within 6 months after initial diagnosis; long term: 60 years)
- The Response Rate of at Least 50%, 75% and 100% Reduction in the Number of Days of Migraine Attacks(Medium term: within 6 months after initial diagnosis; long term: 60 years)
- Days Without Symptoms(Medium term: within 6 months after initial diagnosis; long term: 60 years)
- Migraine Specific Quality of Life Questionnaire (MSQV2.1)(Medium term: within 6 months after initial diagnosis; long term: 60 years)
- Patient Health Questionnaire (PHQ-9)(Medium term: within 6 months after initial diagnosis; long term: 60 years)
- Suicidal Ideation Score (C-SSRS Scale)(Medium term: within 6 months after initial diagnosis; long term: 60 years)
- Susceptibility weighted imaging(SWI) in MRI(Medium term: within 6 months after initial diagnosis; long term: 60 years)
- Diffusion Tensor Imaging(DTI) in MRI(Medium term: within 6 months after initial diagnosis; long term: 60 years)
- Functional Impairment Scale (FIS)(Medium term: within 6 months after initial diagnosis; long term: 60 years)
- Pulse Rate(Medium term: within 6 months after initial diagnosis; long term: 60 years)
- Body Temperature(Medium term: within 6 months after initial diagnosis; long term: 60 years)
- Echocardiography(Medium term: within 6 months after initial diagnosis; long term: 60 years)
- MRI T2 FLIAR(Medium term: within 6 months after initial diagnosis; long term: 60 years)
- Respiratory Rate(Medium term: within 6 months after initial diagnosis; long term: 60 years)
- Body Mass Index (BMI)(Medium term: within 6 months after initial diagnosis; long term: 60 years)
- Magnetic Resonance Imaging(MRI) T1(Medium term: within 6 months after initial diagnosis; long term: 60 years)
- MRI T2(Medium term: within 6 months after initial diagnosis; long term: 60 years)