跳至主要内容
临床试验/NCT03018769
NCT03018769Unknown不适用

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

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine32 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2016年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
2,000
试验地点
32
主要终点
ultrasonic cardiogram

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

研究组 & 干预措施

chronic SCAD

干预措施: Chinese Herb (Drug)

结局指标

主要结局

ultrasonic cardiogram

时间窗: change from take chinese herb in one week

Four diagnostic method of TCM

时间窗: change from take chinese herb in one week

EuroQol-5 Dimensions (EQ-5D)

时间窗: change from take chinese herb in one week

electrocardiograms(ECG)

时间窗: change from take chinese herb in one week

dynamic electrocardiogram

时间窗: change from take chinese herb in one week

treadmill exercise testing (TET)

时间窗: change from take chinese herb in one week

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bi Yingfei

doctor

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

研究点 (32)

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