Study on Dynamic Changes of Serum IGF-1 Post-Cerebral Hemorrhage and Its Prognostic Correlation
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Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Insulin-Like Growth Factor I. Базовые параметры: 18 лет — 75 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
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Официальное название
Study on the Dynamic Changes of Serum IGF-1 After Cerebral Hemorrhage and Its Correlation With Prognosis of Patients
Обзор
The purpose of this study is to dynamically observe the dynamic changes of serum IGF-1 after intracerebral hemorrhage, explore the impact and correlation of serum IGF-1 with the severity of the patient's condition and prognosis, and provide a reference for clinical treatment timing.
Подробное описание
Research Objectives
1. Monitor the dynamic changes in serum IGF-1 concentration in patients with intracerebral hemorrhage at different time points (within 3 days, 14 days, 1 month, 2 months, and 4 months after onset). 2. Analyze the correlation between serum IGF-1 levels and the severity of intracerebral hemorrhage, imaging findings, and prognosis. 3. Explore the clinical value of serum IGF-1 as a biomarker for intracerebral hemorrhage repair. 4. Provide a reference for the clinical treatment timing of IGF-1-related drugs and therapies (such as rh growth hormone, rhIGF-1, etc.).
Experimental Methods
Screening Period:
Within 3 days after onset, record the demographic data, etiology, medical history, complications, disease course, and main clinical manifestations of the subjects during the screening period. Blood sampling for laboratory tests (between 06:00-08:00 in the morning within 3 days after onset) includes: complete blood count, IGF-1, GH, IGFBP-3, LDL-C, thyroid function T4, serum cortisol, ACTH, testosterone or progesterone, serum CRP, fasting blood glucose, glycated hemoglobin. Perform head CT and NIHSS scoring.
Follow-up Period:
At the 15th day, 1st month, and 2nd month of the subject's disease course:
Conduct laboratory tests for IGF-1, GH, and IGFBP-3. Evaluate using the Modified Barthel Index (MBI), Modified Rankin Scale (MRS), Glasgow Coma Scale (GCS), Mini-Mental State Examination (MMSE), PHQ-9 Depression Screening Scale (PHQ-9), and World Health Organization Quality of Life-BREF (WHOQOL-BREF).
At the 4th month of the subject's disease course:
Perform laboratory tests for complete blood count, IGF-1, GH, IGFBP-3, LDL-C, thyroid function T4, serum cortisol, ACTH, testosterone or progesterone, CRP, fasting blood glucose, and glycated hemoglobin.
Evaluate using the same scales as above (MBI, MRS, GCS, MMSE, PHQ-9, WHOQOL-BREF).
Grouping Based on Dynamic Changes in Serum IGF-1:
Convert IGF-1 values to IGF-1 SD (standard deviation) by referencing the age-specific reference values for IGF-1 in healthy Chinese populations (Peking Union Medical College).
IGF-1 Decreased Group: IGF-1 \< 0SD IGF-1 Normal Group: 0SD ≤ IGF-1 ≤ 2SD
Dynamic change-based grouping:
① Persistent IGF-1 Decrease Group: IGF-1 remains \< 0SD throughout dynamic observation.
② IGF-1 Decrease to Normal Group: IGF-1 first \< 0SD, then recovers to \> 0SD.
③ Persistent IGF-1 Normal Group: IGF-1 remains \> 0SD throughout dynamic observation.
Statistical Analysis Based on Experimental Data
Первичные конечные точки
- The relationship between serum IGF-1 levels within 3 days after intracerebral hemorrhage and the severity of the condition (referring to NIHSS score) [Срок оценки: 3 days after intracerebral]
Вторичные конечные точки (1)
- The correlation between the dynamic change trend of IGF-1 after intracerebral hemorrhage and the prognosis of patients [Срок оценки: The 5th month]
Критерии участия
Критерии включения
- Aged 18 to 75 years old;
- Patients with intracerebral hemorrhage (NIHSS ≥5 points);
- No history of cerebrovascular diseases with residual functional impairment before brain injury;
- Hospitalized within 72 hours after injury;
- BMI ≤28.
Критерии исключения
- Patients with severe cardiac, hepatic, renal, or pulmonary dysfunction;
- Glycated hemoglobin >9.0% at screening;
- History of hypothalamic-pituitary related diseases or severe endocrine diseases;
- Use of drugs affecting endocrine function (such as glucocorticoids, growth hormones) within the past six months;
- Pregnant patients. -
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Дизайн исследования
- Модель наблюдения
- Другое
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT07043504 · 2025PS1176K(X1)