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

Tianjin University of Traditional Chinese Medicine

Status: Unknown

Conditions: Chronic Stable Coronary Artery Disease

Treatments: Drug: Chinese Herb

Study type: Observational

Funder types: Other

Identifiers

NCT03018769

FirstTeachingHTianjinUTCM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

2,000 participants in 1 patient group

chronic SCAD

Treatment:

Drug: Chinese Herb