Ignite Creation Date:
2025-12-24 @ 10:08 PM
Ignite Modification Date:
2026-01-05 @ 5:10 PM
Study NCT ID:
NCT03174535
Status:
COMPLETED
Last Update Posted:
2022-04-04
First Post:
2017-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk Assessment Model for Ischemic Stroke Endpoint Events
Sponsor:
China Academy of Chinese Medical Sciences
Organization:
Study Overview
Official Title:
Risk Assessment Model for Ischemic Stroke Endpoint Events Combining Multi-dimensional Traditional Chinese Medicine(TCM) and Modern Medicine Indicators: a Registry Study (Inlaid With a Prospective Cohort Study to Evaluate the Effectiveness of Qilong Capsules)
Status:
COMPLETED
Status Verified Date:
2022-03
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 present study aims to develope a risk assessment model of ischemic stroke endpoint events combining multi-dimensional traditional Chinese medicine(TCM) indicators with modern medicine indicators. The proposed study is a registry study based participant survey conducted in 7 hospitals nationwide in China. After obtaining informed consent, a total of 3000 study patients diagnosed with ischemic stroke will be recruited. 1-year follow-ups are carried out on-site in hospitals and by telephone to track endpoint events. At the same time, we conducted a prospective, multicenter, real-world longitudinal cohort study at 7 hospitals in China to investigate the clinical effectiveness of Qilong capsule (QLC) combined with CT for IS with Qi deficiency and blood stasis syndrome.
Detailed Description:
Stroke is characterized by high incidence and high rates of recurrence and other endpoint events. Risk assessment is important for secondary prevention of ischemic stroke. To date, no study has been conducted to evaluate the risk of ischemic stroke endpoint events by establishing risk accessment models combining TCM and modern medicine indicators.
The present study aims to develope a risk assessment model of ischemic stroke endpoint events combining multi-dimensional TCM indicators with modern medicine indicators. The proposed study is a registry study based participant survey conducted in 7 hospitals nationwide in China. After obtaining informed consent, a total of 3000 study patients diagnosed with ischemic stroke will be recruited. 1-year follow-ups are carried out on-site in hospitals and by telephone to track endpoint events. Comparative analysis of prevalence of endpoint events and other TCM or modern medicine features in different groups is conducted using frequency analysis and chi-squared tests, and expressed with composition ratios. Comparative analysis of quantitative scores of the scales and related syndromes or symptoms is conducted using rank-sum test. Correlation analysis of endpoint events and TCM or modern medicine factors will be performed using multivariate Cox proportional hazard model.
Participants in the exposed group were treated with QLC, and those in the non-exposed group were not treated with QLC. All participants in two groups received standard treatment without restriction. The intervention course of QLC was 12 weeks. All participants returned for in-person follow-up visits at the 12th week and 24th week. Primary outcome measures included a modified Rankin Scale (mRS), the National Institute of Health Stroke Scale (NIHSS), and the Barthel Index (BI). Secondary outcome measures included TCM syndromes (Qi deficiency syndrome score, blood stasis syndrome score), psychological index (self-rating depression scale, SDS; self-rating anxiety scale, SAS), blood lipid index, blood coagulation index, and homocysteine. Multiple imputations were used for any missing data. Propensity score matching (PSM) was used to deal with any confounding factors (age, gender, scale score, etc.). Rank alignment transformation variance analysis (ART ANOVA) and generalized linear mixed model (GLMM) were introduced to improve the scientific and accuracy of repeated measurement data. All statistical calculations were carried out with R 3.6.1 statistical analysis software.
The present study aims to develope a risk assessment model of ischemic stroke endpoint events combining multi-dimensional TCM indicators with modern medicine indicators. The proposed study is a registry study based participant survey conducted in 7 hospitals nationwide in China. After obtaining informed consent, a total of 3000 study patients diagnosed with ischemic stroke will be recruited. 1-year follow-ups are carried out on-site in hospitals and by telephone to track endpoint events. Comparative analysis of prevalence of endpoint events and other TCM or modern medicine features in different groups is conducted using frequency analysis and chi-squared tests, and expressed with composition ratios. Comparative analysis of quantitative scores of the scales and related syndromes or symptoms is conducted using rank-sum test. Correlation analysis of endpoint events and TCM or modern medicine factors will be performed using multivariate Cox proportional hazard model.
Participants in the exposed group were treated with QLC, and those in the non-exposed group were not treated with QLC. All participants in two groups received standard treatment without restriction. The intervention course of QLC was 12 weeks. All participants returned for in-person follow-up visits at the 12th week and 24th week. Primary outcome measures included a modified Rankin Scale (mRS), the National Institute of Health Stroke Scale (NIHSS), and the Barthel Index (BI). Secondary outcome measures included TCM syndromes (Qi deficiency syndrome score, blood stasis syndrome score), psychological index (self-rating depression scale, SDS; self-rating anxiety scale, SAS), blood lipid index, blood coagulation index, and homocysteine. Multiple imputations were used for any missing data. Propensity score matching (PSM) was used to deal with any confounding factors (age, gender, scale score, etc.). Rank alignment transformation variance analysis (ART ANOVA) and generalized linear mixed model (GLMM) were introduced to improve the scientific and accuracy of repeated measurement data. All statistical calculations were carried out with R 3.6.1 statistical analysis software.
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?: