Effects of Integrated Treatment by Traditional Chinese and Western Medicine in Reducing Cardiovascular Events

Prospective Cohort Study on Integrated Treatment by Traditional Chinese and Western Medicine of Patients Diagnosed as CHD (Coronary Heart Disease) With Stable Angina

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Pain; Coronary Disease; Arteriosclerosis; Cardiovascular Disease; Chest Pain; Angina Pectoris; Heart Disease; Signs and Symptoms

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 1042

Contacts and Locations

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130000
      • Jilin Province TCM Institute of Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

treat with combination of standardized western medical drug therapy and Chinese medical continued treatment

Description

Inclusion Criteria:

1. the patients who are according with the II、III stage in CHD western medical diagnosis standard；
2. age between 18 and 75(including 18 and 75)；
3. Signed the informed consent voluntarily.

Exclusion Criteria:

1. The patients whose systolic pressure≥180mmHg and/or diastolic pressure≥110mmHg, have sever insufficiency of heart and lung（cardiac function﹥Ⅱdegree）, sever arrhythmia（rapid atrial fibrillation, atrial flutter,paroxysmal ventricular tachycardia and so on）；
2. the patients who have myocardial infarction or vascular remodeling in last 3 months；
3. hepatic and kidney function obstacle（ALT、AST>1.5 times of normal upper limit value）；
4. the patients who cannot control blood glucose properly（fasting blood glucose>7.0mmol/L and/ or random blood glucose>11.0mmol/L）；
5. the patients who have stroke in late 6 months（lacunar cerebral infarction is not included）；
6. any other sever diseases such as malignant tumor；
7. the patients who attending other clinical study in late 3 months；
8. pregnant or lactating women；
9. the patients who have allergic constitution or are allergic to many drugs.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Integrative Chinese and western medicine; 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 medicine; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary end point all cause death	all because of death, stroke, nonfatal myocardial infarction, revascularization.	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	up to 12months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Angina symptoms	Including the attack times, lasting time, inducing factors of angina attacks, pain degree of angina, discontinue rate of nitroglycerin.	up to 12months
electrocardiogram		up to 12months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
safety indicators	ALT ,AST,BUN,CR,blood routine examination,urine routine	up to 12months

Collaborators and Investigators

• Sponsor: Changchun University of Chinese Medicine
• Investigators: Study Chair: deng yue, dirctor

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2012
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: September 14, 2012
• First Submitted That Met QC Criteria: October 26, 2012
• First Posted (Estimate): October 29, 2012

Study Record Updates

• Last Update Posted (Actual): May 27, 2020
• Last Update Submitted That Met QC Criteria: May 26, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: complementary therapies; traditional chinese medicine; traditional chinese medicine syndrome scale
• Additional Relevant MeSH Terms: Myocardial Ischemia; Vascular Diseases; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Heart Diseases; Coronary Artery Disease; Coronary Disease; Cardiovascular Diseases; Chest Pain; Arteriosclerosis; Angina Pectoris
• Other Study ID Numbers: 201007001-3-1