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Syndrome Differentiation in the Management of Chronic Stable Coronary Artery Disease (SCAD) to Improve Quality

Conditions
Chronic Stable Coronary Artery Disease
Interventions
Drug: Chinese Herb
Registration Number
NCT03018769
Lead Sponsor
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Brief Summary

1.1 To build a TCM diagnosis and treatment database for chronic stable CAD; 1.2 To summarize the pattern of TCM medicine used and the effect of the medication in chronic stable CAD.

1.3 To formulate a syndrome differentiation determined medicine plan based on the improvement in the quality of life on chronic stable CAD patients.

Detailed Description

Chronic stable coronary artery disease (SCAD) is a general term for all kinds of coronary artery disease (CAD) which includes patients with chronic stable angina, oldmyocardial infarctions and also stable condition after revascularization (i.e percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG)). According to 2012 American Heart Association/American College of Cardiology (AHA/ACC) guide, the objective of the treatment for SCAD is to maintain or recover patients' exercise tolerance, quality of life and avoid complication like heart failure,so as to decrease mortality, eliminate symptoms and avoid adverse reactions.

Traditional Chinese medicine (TCM) has two thousand years of history in managing CAD and has its advantages in improving quality of life. Using scientific method to evaluate, demonstrate and conclude the clinical curative effect of TCM is an extremely important task for both TCM and Chinese and western integrative medicine win the treatment of CAD. Recent researches mainly focus on certain types or some certain pathological and physiological stages of CAD, worse still, different areas experts have their own experiences and opinions with the treatment. There is a lack of unified syndrome differentiation and prescriptions plan for the chronic stable CAD and not enough attention has been paid to TCM despite it having many advantages in improving quality of life in these patients. Considering all the above, this research studied past syndromes research results and real clinical effective chronic SCAD cases. Cases were analysed and explored, effective cases were filtered, syndrome differentiation of the prescriptions was refined, thus build a TCM diagnosis and treatment information database.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
2000
Inclusion Criteria
  • without age limit
  • diagnose as chronic SCAD at first visit
  • heart function classification between II~III Canada classification(CCS)
  • Be willing to accept Chinese herbal decoction
  • sign an informed consent
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Exclusion Criteria
  • suffer from acute myocardial infarction (AMI) ,unstable angina or prior revascularization(i.e PCI,CABG) in the latest 60 days .
  • have such diseases as follow: a.poorly controlled blood pressure even taken medicine(systolic pressure≥180mmHg, diastolic pressure≥100mmHg); - severe arrhythmia(atrial fibrillation with rapid ventricular response, atrial flutter, paroxysmal ventricular tachycardia, etc); c.pulmonary heart disease, rheumatic heart disease, myocarditis, cardiomyopathy, aortic dissection, pulmonary embolism.
  • hyperthyreosis, cervical spondylosis, gallbladder-cardiac syndrome, gastroesophageal reflux, esophageal hiatal hernia, neurosis, climacteric syndrome and other diseases which would cause chest pain.
  • alanine transaminase(ALT) or serum creatinine(Scr) more than twice the normal reference value.
  • hemoglobin(Hb)<100g/L or have severe hematological system disease.
  • malignant tumor.
  • pregnant, lactating women or other women have reproductive requirement.
  • psychosis or cognition impairment person.
  • taken chinese medicine decoction in recent two weeks.
  • not take part in any other clinical trail.
Read More

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
chronic SCADChinese Herb-
Primary Outcome Measures
NameTimeMethod
ultrasonic cardiogramchange from take chinese herb in one week
Four diagnostic method of TCMchange from take chinese herb in one week
EuroQol-5 Dimensions (EQ-5D)change from take chinese herb in one week
electrocardiograms(ECG)change from take chinese herb in one week
dynamic electrocardiogramchange from take chinese herb in one week
treadmill exercise testing (TET)change from take chinese herb in one week
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (32)

Beijing Hospital of Traditional Chinese Medicine

🇨🇳

Beijing, China

Dongfang Hospital of Beijing University of Chinese Medicine

🇨🇳

Beijing, China

Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine

🇨🇳

Beijing, China

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

🇨🇳

Beijing, China

the third Affiliated to Beijing University of Chinese Medicine

🇨🇳

Beijing, China

Xiyuan Hospital of China Academy of Chinese Medical Sciences

🇨🇳

Beijing, China

Affiliated Hospital of Changchun University of Traditional Chinese Medicine

🇨🇳

Changchun, China

Affiliated Hospital of Gansu University of Chinese Medicine

🇨🇳

Gansu, China

Guangdong Provincial Hospital of Chinese Medicine

🇨🇳

Guangdong, China

The First Affiliated Hospital of Henan University of TCM

🇨🇳

Henan, China

Guangdong Second Troditional Chinese Medicine Hospital

🇨🇳

Guangdong, China

First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine

🇨🇳

Guangzhou, China

Henan Province Hospital of TCM

🇨🇳

Henan, China

Affiliated Hospital of Hunan Academy of Chinese Medicine

🇨🇳

Hunan, China

Jiangsu Province Hospital of TCM

🇨🇳

Jiangsu, China

The Second Affiliated Traditional hospital of Hunan University of Traditional Chinese Medicine

🇨🇳

Hunan, China

The First Hospital of Hunan University of Chinese Medicine

🇨🇳

Hunan, China

Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

🇨🇳

Liaoning, China

Jiangxi Provincial Hospital of Chinese Medicine

🇨🇳

Jiangxi, China

The Second Affiliated Hospital of Liaoning University of traditional Chinese Medicine

🇨🇳

Liaoning, China

Shanxi Province Hospital of Traditional Chinese Medicine

🇨🇳

Shanxi, China

Shanxi Hospital of Traditional Chinese Medicine

🇨🇳

Shanxi, China

Shandong Province Hospital of Traditional Chinese Medicine

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Shandong, China

The Affiliated Hospital to Shanxi University of Traditional Chinese Medicine

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Shanxi, China

The Second Affiliated Hospital of Shanxi University of Traditional Chinese Medcine

🇨🇳

Shanxi, China

Shijiazhuang Traditional Chinese Medicine Hospita

🇨🇳

Shijiazhuang, China

First Teaching Hospital of Tianjin University of TCM

🇨🇳

Tianjin, China

Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital

🇨🇳

Tianjin, China

Second Affiliated Hospital of Tianjin University of TCM

🇨🇳

Tianjin, China

Traditional Chinese Medicine Hospital of Xinjiang Uygur Autonomous Region

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Xinjiang, China

The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

🇨🇳

Anhui, China

Heilongjiang Provincial Hospital of traditional Chinese Medicine

🇨🇳

Heilongjiang, China

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