China Headache and Vertigo Registry Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Moderate / Severe Headache Days
研究概览
简要总结
In the Chinese 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 Chinese 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. 3. In order to ensure the quality of the trial, the sponsor and the researcher shall discuss and formulate the clinical research plan before the trial officially begins. GCP training was given to the relevant researchers who participated in the experiment. The research center must manage experimental drugs in accordance with (SOP), including receipt, storage, distribution and recycling. In accordance with the GCP guidelines, necessary steps should be taken during the design and implementation phase of the study to ensure that the data collected are accurate, consistent, complete and credible. All observed results and abnormal findings in clinical trials should be verified and recorded in time to ensure the reliability of the data. The instruments, equipment, reagents and standards used in various examination items in clinical trials should have strict quality standards and ensure that they work under normal conditions. The researcher inputs the information required by the program into the eCRF, and the inspector verifies whether the filling is complete and accurate, and instructs the staff of the research center to make necessary corrections and supplements. The drug regulatory department, the institutional review committee (IRB)
/ independent ethics committee (IEC), sponsor inspectors and / or inspectors may conduct systematic inspections of clinical trial-related activities and documents to evaluate whether trials are conducted in accordance with the requirements of the study program, SOP and relevant regulations (e.g. GCP, GMP), and whether trial data are recorded in a timely, true, accurate and complete manner. The inspection should be carried out by personnel who are not directly involved in the clinical trial. In order to meet the audit and / or inspection requirements of the regulator
, the researcher / institution must agree to keep the relevant records, including the identification numbers of all subjects (sufficient information is linked to the records, such as eCRF and hospital records), all originally signed informed consent forms. All eCRF copies, safety report forms, original records, treatment details, related communication documents (such as letters, meeting minutes, phone reports). Researchers / institutions are required to keep records in accordance with relevant specifications.
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
- •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.
- •Headache patients meeting the diagnostic criteria for ICHD-3, including primary headaches such as migraine and tension tension-type headaches, secondary headaches.
- •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: 30 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.
Vertigo attack
时间窗: Medium term: within 6 months after initial diagnosis; long term: 30 years
Vertigo is a sensation of feeling off balance. Vertigo attack is defined as any vertigo or dizziness attacks, such as the condition where person has the sensation of moving or of surrounding objects moving when they are not. Some questionnaires, such as the dizziness handicap inventory (DHI) and Vertigo Symptom Scale (VSS) are used to assess the severity of vertigo. The differential diagnosis of vertigo or dizziness can be narrowed with easy-to-perform physical examination tests, including evaluation for nystagmus, the Dix Hallpike maneuver, and orthostatic blood pressure testing.
Days of Migraine
时间窗: Medium term: within 6 months after initial diagnosis; long term: 30 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
- 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: 30 years)
- Headache Intensity(Medium term: within 6 months after initial diagnosis; long term: 30 years)
- Days Without Headache(Medium term: within 6 months after initial diagnosis; long term: 30 years)
- Peak Headache Pain Intensity(Medium term: within 6 months after initial diagnosis; long term: 30 years)
- Acute Medication Use Day(Medium term: within 6 months after initial diagnosis; long term: 30 years)
- Cumulative Hours of Moderate / Severe Pain(Medium term: within 6 months after initial diagnosis; long term: 30 years)
- Days Without Symptoms(Medium term: within 6 months after initial diagnosis; long term: 30 years)
- Migraine Disability Assessment (MIDAS)(Medium term: within 6 months after initial diagnosis; long term: 30 years)
- Patient Global Impression of Change (PGIC)(Medium term: within 6 months after initial diagnosis; long term: 30 years)
- Physical Measurements(Medium term: within 6 months after initial diagnosis; long term: 30 years)
- Genetic analysis of familial headache and vertigo(Medium term: within 6 months after initial diagnosis; long term: 30 years)
- Migraine Attack(Medium term: within 6 months after initial diagnosis; long term: 30 years)
- Activity Impairment in Migraine - Diary (AIM-D)(Medium term: within 6 months after initial diagnosis; long term: 30 years)
- European Quality of Life - 5 Dimensional (EQ-5D-5L)(Medium term: within 6 months after initial diagnosis; long term: 30 years)
- Functional Impairment Scale (FIS)(Medium term: within 6 months after initial diagnosis; long term: 30 years)
- Patient Difficulty in Concentrating, Difficulty in Thinking Clearly, Activity Level, and Activity Limitation(Medium term: within 6 months after initial diagnosis; long term: 30 years)
- Work Productivity and Activity Impairment Questionnaire Migraine V2.0 (WPAI:MIGRAINE)(Medium term: within 6 months after initial diagnosis; long term: 30 years)
- Headache Impact Test (HIT-6)(Medium term: within 6 months after initial diagnosis; long term: 30 years)
- Patient Global Impression - Severity (PGI-S)(Medium term: within 6 months after initial diagnosis; long term: 30 years)
- Generalized Anxiety Disorder (GAD-7)(Medium term: within 6 months after initial diagnosis; long term: 30 years)
- Physical Examination(Medium term: within 6 months after initial diagnosis; long term: 30 years)
- Migraine Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1)(Medium term: within 6 months after initial diagnosis; long term: 30 years)
- Patient-Reported Outcomes Measurement Information System Pain Interference - Short Form 6a (PROMIS-PI)(Medium term: within 6 months after initial diagnosis; long term: 30 years)
- Columbia-Suicide Severity Rating Scale(Medium term: within 6 months after initial diagnosis; long term: 30 years)
- Migraine Physiological Function Influence Diary (MPFID)(Medium term: within 6 months after initial diagnosis; long term: 30 years)
- Biomarkers of primary headache and vertigo(Medium term: within 6 months after initial diagnosis; long term: 30 years)
- Safety Measures, Adverse Events and Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(Medium term: within 6 months after initial diagnosis; long term: 30 years)
- Medical and Medication History(Medium term: within 6 months after initial diagnosis; long term: 30 years)