Risk Assessment Model for Ischemic Stroke Endpoint Events

Ischemic Stroke Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03174535
• Other study ID #: 201507003-8
• Status: Completed
• Start date: November 15, 2016
• Est. completion date: January 31, 2019

Study information

• Verified date: March 2022
• Source: China Academy of Chinese Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: January 31, 2019
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 80 Years

Eligibility

Inclusion Criteria:

(1) Meeting diagnostic criteria of ischemic stroke; (2) Meeting large-artery atherosclerosis or small-artery occlusion subtypes of ischemic stroke according to TOAST (The Trial of Org 10172 in Acute Stroke Treatment) classification [29]; (3) In the first 2 weeks of the first onset should account for no less than 50% of all the included cases; (4) 38-80 years of age; (5) Willing to respond truthfully and timely to researcher queries after recruitment, able to cooperate with data and sample collection during follow-ups; (6) Willing to sign informed consent.

Exclusion Criteria:

(1) Meeting diagnostic criteria of transient ischemic attack (TIA), hemorrhagic stroke, or mixed stroke; (2) Meeting cardioembolism, other determined or undetermined etiology subtypes of ischemic stroke according to TOAST classification [29]; (3) Unable to participate in data or sample collection for any reason.

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• Qilong capsules (QLC), produced by Jining Huaneng Pharmaceutical Factory Co., Ltd.
The recommended dosage of QLC was 0.4g each time, 3 times a day. The course of treatment was 12 weeks.

Locations

Country	Name	City	State
China	Yanming Xie	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ischemic stroke recurrence events	Including cerebral infarction, cerebral hemorrhage and TIA	1 year follow-up
Primary	mRS, NIHSS, BI	modified Rankin Scale (mRS), the National Institute of Health Stroke Scale (NIHSS), and the Barthel Index (BI)	All participants returned for in-person follow-up visits at the 12th week and 24th week.
Secondary	death, disability, and endpoint events of atherosclerotic cardiovascular disease and atherosclerotic peripheral vascular disease	Including ischemic stroke caused death and disability, and endpoint events of atherosclerotic cardiovascular disease and atherosclerotic peripheral vascular disease.	1 year follow-up
Secondary	TCM syndromes, psychological index, blood lipid index,blood coagulation index, and homocysteine	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.	All participants returned for in-person follow-up visits at the 12th week and 24th week.