An observational study in Angina Pectoris, Coronary Artery Disease and Coronary Disease, sponsored by Changchun University of Chinese Medicine. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-27.
Sponsored by Changchun University of Chinese Medicine · Observational
Compared with standardized western medical drug therapy, this study is mainly about whether the combination of standardized western medical drug therapy and Chinese medical continued treatment, can further decrease the rate of cardiovascular events for stable angina patients and change the condition of angina.
We will pick 1100 patients who are according with the II、III stage in CHD western medical diagnosis standard, treat them with combination of standardized western medical drug therapy and Chinese medical continued treatment, or only with standardized western medical drug therapy,the treat course will last 6 months. The patients will be separated in two groups: Integrative treatment of Chinese medicine and western medicine group(integrative group) and western medical group according to the exposure factors(whether the patients accept differentiation of TCM ) during the follow-up period, observe the main indexes: Primary Endpoint: all because of death, stroke, nonfatal myocardial infarction, revascularization. Secondary endpoint: the events needed hospitalization which are because of (acute coronary syndrome)ACS,heart failure, severe arrhythmia, and complications. Secondary indexes: angina symptoms. Including the attack times, lasting time, inducing factors of angina attacks, pain degree of angina, discontinue rate of nitroglycerin, and electrocardiogram.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 920 are open to participants now.
This study's enrollment of 1,042 is above the median of 573 across 1,483 observational studies indexed under Cardiovascular Diseases.
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treat with combination of standardized western medical drug therapy and Chinese medical continued treatment
Exclusion Criteria:
Integrative Chinese and western medicine group treat with western medical therapy for CHD refering to the 'Chronic stable angina pectoris diagnosis and treatment guide'which is published by Chinese society of Cardiology, Chinese Medical Association in March, 2007, including the anti-ischemia treatment(nitric acid ester,β-blocker,calcium antagonist,ACEI), anti platelet therapy(aspirin and/or clopidogrel) and other statins.TCM should be confirmed by the physicians, according to the syndrome differentiation and the treat plan recommended in this study.
western medical therapy for CHD can refer to the 'Chronic stable angina pectoris diagnosis and treatment guide'which is published by Chinese society of Cardiology, Chinese Medical Association in March, 2007, including the anti-ischemia treatment(nitric acid ester,β-blocker,calcium antagonist,ACEI), anti platelet therapy(aspirin and/or clopidogrel) and other statins.
Primary end point all cause death
all because of death, stroke, nonfatal myocardial infarction, revascularization.
Time frame: up to 12 months
Secondary endpoint hospitalization
the events needed hospitalization which are because of (acute coronary syndrome)ACS,heart failure, severe arrhythmia, and complications
Time frame: up to 12months
Angina symptoms
Including the attack times, lasting time, inducing factors of angina attacks, pain degree of angina, discontinue rate of nitroglycerin.
Time frame: up to 12months
electrocardiogram
Time frame: up to 12months
safety indicators
ALT ,AST,BUN,CR,blood routine examination,urine routine
Time frame: up to 12months
This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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Changchun University of Chinese Medicine