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

NCT ID: NCT03018769

Last Updated: 2017-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-31

Study Completion Date

2017-12-31

Brief Summary

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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

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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.

Conditions

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Chronic Stable Coronary Artery Disease

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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chronic SCAD

Chinese Herb

Intervention Type DRUG

Interventions

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Chinese Herb

Intervention Type DRUG

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Bi Yingfei

doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Anhui, , China

Site Status RECRUITING

Beijing Hospital of Traditional Chinese Medicine

Beijing, , China

Site Status RECRUITING

Dongfang Hospital of Beijing University of Chinese Medicine

Beijing, , China

Site Status RECRUITING

Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine

Beijing, , China

Site Status RECRUITING

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Beijing, , China

Site Status RECRUITING

the third Affiliated to Beijing University of Chinese Medicine

Beijing, , China

Site Status RECRUITING

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Beijing, , China

Site Status RECRUITING

Affiliated Hospital of Changchun University of Traditional Chinese Medicine

Changchun, , China

Site Status RECRUITING

Affiliated Hospital of Gansu University of Chinese Medicine

Gansu, , China

Site Status RECRUITING

Guangdong Provincial Hospital of Chinese Medicine

Guangdong, , China

Site Status RECRUITING

Guangdong Second Troditional Chinese Medicine Hospital

Guangdong, , China

Site Status RECRUITING

First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine

Guangzhou, , China

Site Status RECRUITING

Heilongjiang Provincial Hospital of traditional Chinese Medicine

Heilongjiang, , China

Site Status RECRUITING

Henan Province Hospital of TCM

Henan, , China

Site Status RECRUITING

The First Affiliated Hospital of Henan University of TCM

Henan, , China

Site Status RECRUITING

Affiliated Hospital of Hunan Academy of Chinese Medicine

Hunan, , China

Site Status RECRUITING

The First Hospital of Hunan University of Chinese Medicine

Hunan, , China

Site Status RECRUITING

The Second Affiliated Traditional hospital of Hunan University of Traditional Chinese Medicine

Hunan, , China

Site Status RECRUITING

Jiangsu Province Hospital of TCM

Jiangsu, , China

Site Status RECRUITING

Jiangxi Provincial Hospital of Chinese Medicine

Jiangxi, , China

Site Status RECRUITING

Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

Liaoning, , China

Site Status RECRUITING

The Second Affiliated Hospital of Liaoning University of traditional Chinese Medicine

Liaoning, , China

Site Status RECRUITING

Shandong Province Hospital of Traditional Chinese Medicine

Shandong, , China

Site Status RECRUITING

Shanxi Hospital of Traditional Chinese Medicine

Shanxi, , China

Site Status RECRUITING

Shanxi Province Hospital of Traditional Chinese Medicine

Shanxi, , China

Site Status RECRUITING

The Affiliated Hospital to Shanxi University of Traditional Chinese Medicine

Shanxi, , China

Site Status RECRUITING

The Second Affiliated Hospital of Shanxi University of Traditional Chinese Medcine

Shanxi, , China

Site Status RECRUITING

Shijiazhuang Traditional Chinese Medicine Hospita

Shijiazhuang, , China

Site Status RECRUITING

First Teaching Hospital of Tianjin University of TCM

Tianjin, , China

Site Status RECRUITING

Second Affiliated Hospital of Tianjin University of TCM

Tianjin, , China

Site Status RECRUITING

Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital

Tianjin, , China

Site Status RECRUITING

Traditional Chinese Medicine Hospital of Xinjiang Uygur Autonomous Region

Xinjiang, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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bi mr yingfei, doctor

Role: CONTACT

022-27432327

jingyuan mr mao, doctor

Role: CONTACT

022-27432327

Other Identifiers

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FirstTeachingHTianjinUTCM

Identifier Type: -

Identifier Source: org_study_id

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