Clinical trial NCT03018769: Syndrome Differentiation in the Management of Chronic Stable Coronary Artery Disease (SCAD) to Improve Quality
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Stable Coronary Artery Disease
Lead sponsor: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2017-01-12
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: chronic stable Coronary Artery Disease

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.

Eligibility criteria: 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

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.

Primary outcomes:
measure: EuroQol-5 Dimensions (EQ-5D)
timeFrame: change from take chinese herb in one week
measure: Four diagnostic method of TCM
timeFrame: change from take chinese herb in one week
measure: electrocardiograms(ECG)
timeFrame: change from take chinese herb in one week
measure: dynamic electrocardiogram
timeFrame: change from take chinese herb in one week
measure: ultrasonic cardiogram
timeFrame: change from take chinese herb in one week
measure: treadmill exercise testing (TET)
timeFrame: change from take chinese herb in one week
Secondary outcomes:
Other outcomes:
Locations:
city: Anhui
country: China
facility: The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
city: Beijing
country: China
facility: Beijing Hospital of Traditional Chinese Medicine
city: Beijing
country: China
facility: Dongfang Hospital of Beijing University of Chinese Medicine
city: Beijing
country: China
facility: Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
city: Beijing
country: China
facility: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
city: Beijing
country: China
facility: the third Affiliated to Beijing University of Chinese Medicine
city: Beijing
country: China
facility: Xiyuan Hospital of China Academy of Chinese Medical Sciences
city: Changchun
country: China
facility: Affiliated Hospital of Changchun University of Traditional Chinese Medicine
city: Gansu
country: China
facility: Affiliated Hospital of Gansu University of Chinese Medicine
city: Guangdong
country: China
facility: Guangdong Provincial Hospital of Chinese Medicine
city: Guangdong
country: China
facility: Guangdong Second Troditional Chinese Medicine Hospital
city: Guangzhou
country: China
facility: First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
city: Heilongjiang
country: China
facility: Heilongjiang Provincial Hospital of traditional Chinese Medicine
city: Henan
country: China
facility: Henan Province Hospital of TCM
city: Henan
country: China
facility: The First Affiliated Hospital of Henan University of TCM
city: Hunan
country: China
facility: Affiliated Hospital of Hunan Academy of Chinese Medicine
city: Hunan
country: China
facility: The First Hospital of Hunan University of Chinese Medicine
city: Hunan
country: China
facility: The Second Affiliated Traditional hospital of Hunan University of Traditional Chinese Medicine
city: Jiangsu
country: China
facility: Jiangsu Province Hospital of TCM
city: Jiangxi
country: China
facility: Jiangxi Provincial Hospital of Chinese Medicine
city: Liaoning
country: China
facility: Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
city: Liaoning
country: China
facility: The Second Affiliated Hospital of Liaoning University of traditional Chinese Medicine
city: Shandong
country: China
facility: Shandong Province Hospital of Traditional Chinese Medicine
city: Shanxi
country: China
facility: Shanxi Hospital of Traditional Chinese Medicine
city: Shanxi
country: China
facility: Shanxi Province Hospital of Traditional Chinese Medicine
city: Shanxi
country: China
facility: The Affiliated Hospital to Shanxi University of Traditional Chinese Medicine
city: Shanxi
country: China
facility: The Second Affiliated Hospital of Shanxi University of Traditional Chinese Medcine
city: Shijiazhuang
country: China
facility: Shijiazhuang Traditional Chinese Medicine Hospita
city: Tianjin
country: China
facility: First Teaching Hospital of Tianjin University of TCM
city: Tianjin
country: China
facility: Second Affiliated Hospital of Tianjin University of TCM
city: Tianjin
country: China
facility: Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
city: Xinjiang
country: China
facility: Traditional Chinese Medicine Hospital of Xinjiang Uygur Autonomous Region
Study officials:
References: