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

January 12, 2017 updated by: Bi Yingfei, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Anhui, China
        • Recruiting
        • The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
      • Beijing, China
        • Recruiting
        • Xiyuan Hospital of China Academy of Chinese Medical Sciences
      • Beijing, China
        • Recruiting
        • Beijing Hospital of Traditional Chinese Medicine
      • Beijing, China
        • Recruiting
        • Dongfang Hospital of Beijing University of Chinese Medicine
      • Beijing, China
        • Recruiting
        • Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
      • Beijing, China
        • Recruiting
        • Guang'anmen Hospital of China Academy of Chinese Medical Sciences
      • Beijing, China
        • Recruiting
        • the third Affiliated to Beijing University of Chinese Medicine
      • Changchun, China
        • Recruiting
        • Affiliated Hospital of Changchun University of Traditional Chinese Medicine
      • Gansu, China
        • Recruiting
        • Affiliated Hospital of Gansu University of Chinese Medicine
      • Guangdong, China
        • Recruiting
        • Guangdong Provincial Hospital of Chinese Medicine
      • Guangdong, China
        • Recruiting
        • Guangdong Second Troditional Chinese Medicine Hospital
      • Guangzhou, China
        • Recruiting
        • First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
      • Heilongjiang, China
        • Recruiting
        • Heilongjiang Provincial Hospital of Traditional Chinese Medicine
      • Henan, China
        • Recruiting
        • Henan Province Hospital of TCM
      • Henan, China
        • Recruiting
        • The first affiliated hospital of henan university of TCM
      • Hunan, China
        • Recruiting
        • Affiliated Hospital of Hunan Academy of Chinese Medicine
      • Hunan, China
        • Recruiting
        • The First Hospital of Hunan University of Chinese Medicine
      • Hunan, China
        • Recruiting
        • The Second Affiliated Traditional hospital of Hunan University of Traditional Chinese Medicine
      • Jiangsu, China
        • Recruiting
        • Jiangsu province hospital of TCM
      • Jiangxi, China
        • Recruiting
        • Jiangxi Provincial Hospital of Chinese Medicine
      • Liaoning, China
        • Recruiting
        • Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
      • Liaoning, China
        • Recruiting
        • The Second Affiliated Hospital of Liaoning University of traditional Chinese Medicine
      • Shandong, China
        • Recruiting
        • Shandong Province Hospital of Traditional Chinese Medicine
      • Shanxi, China
        • Recruiting
        • Shanxi Hospital of Traditional Chinese Medicine
      • Shanxi, China
        • Recruiting
        • Shanxi Province Hospital of Traditional Chinese Medicine
      • Shanxi, China
        • Recruiting
        • The Affiliated Hospital to Shanxi University of Traditional Chinese Medicine
      • Shanxi, China
        • Recruiting
        • The Second Affiliated Hospital of Shanxi University of Traditional Chinese Medcine
      • Shijiazhuang, China
        • Recruiting
        • Shijiazhuang Traditional Chinese Medicine Hospita
      • Tianjin, China
        • Recruiting
        • Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
      • Tianjin, China
        • Recruiting
        • First Teaching Hospital of Tianjin University of TCM
      • Tianjin, China
        • Recruiting
        • Second affiliated hospital of Tianjin university of tcm
      • Xinjiang, China
        • Recruiting
        • Traditional Chinese Medicine Hospital of Xinjiang Uygur Autonomous Region

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

chronic stable Coronary Artery Disease

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
chronic SCAD
Drug: Chinese Herb

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
EuroQol-5 Dimensions (EQ-5D)
Time Frame: change from take chinese herb in one week
change from take chinese herb in one week
Four diagnostic method of TCM
Time Frame: change from take chinese herb in one week
change from take chinese herb in one week
electrocardiograms(ECG)
Time Frame: change from take chinese herb in one week
change from take chinese herb in one week
dynamic electrocardiogram
Time Frame: change from take chinese herb in one week
change from take chinese herb in one week
ultrasonic cardiogram
Time Frame: change from take chinese herb in one week
change from take chinese herb in one week
treadmill exercise testing (TET)
Time Frame: change from take chinese herb in one week
change from take chinese herb in one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (ANTICIPATED)

December 1, 2017

Study Completion (ANTICIPATED)

December 1, 2017

Study Registration Dates

First Submitted

January 7, 2017

First Submitted That Met QC Criteria

January 11, 2017

First Posted (ESTIMATE)

January 12, 2017

Study Record Updates

Last Update Posted (ESTIMATE)

January 13, 2017

Last Update Submitted That Met QC Criteria

January 12, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FirstTeachingHTianjinUTCM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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