Syndrome Differentiation in the Management of Chronic Stable Coronary Artery Disease (SCAD) to Improve Quality
1 other identifier
observational
2,000
1 country
32
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2016
Shorter than P25 for all trials
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 7, 2017
CompletedFirst Posted
Study publicly available on registry
January 12, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedJanuary 13, 2017
January 1, 2017
1 year
January 7, 2017
January 12, 2017
Conditions
Outcome Measures
Primary Outcomes (6)
EuroQol-5 Dimensions (EQ-5D)
change from take chinese herb in one week
Four diagnostic method of TCM
change from take chinese herb in one week
electrocardiograms(ECG)
change from take chinese herb in one week
dynamic electrocardiogram
change from take chinese herb in one week
ultrasonic cardiogram
change from take chinese herb in one week
treadmill exercise testing (TET)
change from take chinese herb in one week
Study Arms (1)
chronic SCAD
Interventions
Eligibility Criteria
chronic stable Coronary Artery Disease
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Anhui, China
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
Guangdong Second Troditional Chinese Medicine Hospital
Guangdong, China
First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
Guangzhou, China
Heilongjiang Provincial Hospital of traditional Chinese Medicine
Heilongjiang, China
Henan Province Hospital of TCM
Henan, China
The First Affiliated Hospital of Henan University of TCM
Henan, China
Affiliated Hospital of Hunan Academy of Chinese Medicine
Hunan, China
The First Hospital of Hunan University of Chinese Medicine
Hunan, China
The Second Affiliated Traditional hospital of Hunan University of Traditional Chinese Medicine
Hunan, China
Jiangsu Province Hospital of TCM
Jiangsu, China
Jiangxi Provincial Hospital of Chinese Medicine
Jiangxi, China
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Liaoning, China
The Second Affiliated Hospital of Liaoning University of traditional Chinese Medicine
Liaoning, China
Shandong Province Hospital of Traditional Chinese Medicine
Shandong, China
Shanxi Hospital of Traditional Chinese Medicine
Shanxi, China
Shanxi Province Hospital of Traditional Chinese Medicine
Shanxi, China
The Affiliated Hospital to Shanxi University of Traditional Chinese Medicine
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
Second Affiliated Hospital of Tianjin University of TCM
Tianjin, China
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
Tianjin, China
Traditional Chinese Medicine Hospital of Xinjiang Uygur Autonomous Region
Xinjiang, China
MeSH Terms
Interventions
Central Study Contacts
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- doctor
Study Record Dates
First Submitted
January 7, 2017
First Posted
January 12, 2017
Study Start
December 1, 2016
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
January 13, 2017
Record last verified: 2017-01