Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2026-01-01 @ 10:38 PM
Study NCT ID:
NCT07043504
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-29
First Post:
2025-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on Dynamic Changes of Serum IGF-1 Post-Cerebral Hemorrhage and Its Prognostic Correlation
Sponsor:
Shengjing Hospital
Organization:
Study Overview
Official Title:
Study on the Dynamic Changes of Serum IGF-1 After Cerebral Hemorrhage and Its Correlation With Prognosis of Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: