Chronic Stable Coronary Artery DiseaseNCT03018769
Syndrome Differentiation in the Management of Chronic Stable Coronary Artery Disease (SCAD) to Improve Quality
An observational study of Chronic Stable Coronary Artery Disease, run by First Teaching Hospital of Tianjin University of Traditional Chinese Medicine at 32 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Chronic Stable Coronary Artery Disease
- What is being tested?
- Chinese Herb
- How many people
- 2,000 participants
- Where
- 32 sitesChina
- Study dates
- Dec 2016to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: chronic stable Coronary Artery Disease
Who may be able to join
- 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
Who cannot join
- 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.
Show all 10Show fewer
- 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 locations and contacts
32 sites in 1 country.
32 sites in 1 country
China32 sites, 32 recruiting
- Recruiting
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Anhui
- Recruiting
Beijing Hospital of Traditional Chinese Medicine
Beijing
- Recruiting
Dongfang Hospital of Beijing University of Chinese Medicine
Beijing
- Recruiting
Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
Beijing
- Recruiting
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Beijing
- Recruiting
the third Affiliated to Beijing University of Chinese Medicine
Beijing
- Recruiting
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Beijing
- Recruiting
Affiliated Hospital of Changchun University of Traditional Chinese Medicine
Changchun
- Recruiting
Affiliated Hospital of Gansu University of Chinese Medicine
Gansu
- Recruiting
Guangdong Provincial Hospital of Chinese Medicine
Guangdong
- Recruiting
Guangdong Second Troditional Chinese Medicine Hospital
Guangdong
- Recruiting
First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
Guangzhou
- Recruiting
Heilongjiang Provincial Hospital of traditional Chinese Medicine
Heilongjiang
- Recruiting
Henan Province Hospital of TCM
Henan
- Recruiting
The First Affiliated Hospital of Henan University of TCM
Henan
- Recruiting
Affiliated Hospital of Hunan Academy of Chinese Medicine
Hunan
- Recruiting
The First Hospital of Hunan University of Chinese Medicine
Hunan
- Recruiting
The Second Affiliated Traditional hospital of Hunan University of Traditional Chinese Medicine
Hunan
- Recruiting
Jiangsu Province Hospital of TCM
Jiangsu
- Recruiting
Jiangxi Provincial Hospital of Chinese Medicine
Jiangxi
- Recruiting
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Liaoning
- Recruiting
The Second Affiliated Hospital of Liaoning University of traditional Chinese Medicine
Liaoning
- Recruiting
Shandong Province Hospital of Traditional Chinese Medicine
Shandong
- Recruiting
Shanxi Hospital of Traditional Chinese Medicine
Shanxi
- Recruiting
Shanxi Province Hospital of Traditional Chinese Medicine
Shanxi
- Recruiting
The Affiliated Hospital to Shanxi University of Traditional Chinese Medicine
Shanxi
- Recruiting
The Second Affiliated Hospital of Shanxi University of Traditional Chinese Medcine
Shanxi
- Recruiting
Shijiazhuang Traditional Chinese Medicine Hospita
Shijiazhuang
- Recruiting
First Teaching Hospital of Tianjin University of TCM
Tianjin
- Recruiting
Second Affiliated Hospital of Tianjin University of TCM
Tianjin
- Recruiting
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
Tianjin
- Recruiting
Traditional Chinese Medicine Hospital of Xinjiang Uygur Autonomous Region
Xinjiang
About this study
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.
Read the 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.
- Conditions
- Chronic Stable Coronary Artery Disease
- Being tested
- Chinese Herb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese HerbDrug
| Study group | Role | What they receive |
|---|---|---|
| chronic SCAD | Not described Receives: Drug: Chinese Herb |
What is being measured
The primary outcome is the main question the study is designed to answer.
EuroQol-5 Dimensions (EQ-5D)
Measured: change from take chinese herb in one week
Four diagnostic method of TCM
Measured: change from take chinese herb in one week
electrocardiograms(ECG)
Measured: change from take chinese herb in one week
dynamic electrocardiogram
Measured: change from take chinese herb in one week
ultrasonic cardiogram
Measured: change from take chinese herb in one week
treadmill exercise testing (TET)
Measured: change from take chinese herb in one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2017 (estimated)
- Study startDec 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Stable Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bi Yingfei, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03018769
- Sponsor's protocol ID
- FirstTeachingHTianjinUTCM
- Status last verified
- Jan 2017
- First submitted
- 7 Jan 2017
- Last updated
- 13 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Syndrome Differentiation in the Management of Chronic Stable Coronary Artery Disease (SCAD) to Improve Quality
- ClinicalTrials.gov ID
- NCT03018769
- Acronym / sponsor ID
- FirstTeachingHTianjinUTCM
- Conditions
- Chronic Stable Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- First Teaching Hospital of Tianjin University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 12 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chronic SCAD | – | Drug: Chinese Herb |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- chronic stable Coronary Artery Disease
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chinese Herb | Drug | chronic SCAD |
Primary outcome
EuroQol-5 Dimensions (EQ-5D)
Time frame: change from take chinese herb in one week
Four diagnostic method of TCM
Time frame: change from take chinese herb in one week
electrocardiograms(ECG)
Time frame: change from take chinese herb in one week
dynamic electrocardiogram
Time frame: change from take chinese herb in one week
ultrasonic cardiogram
Time frame: change from take chinese herb in one week
treadmill exercise testing (TET)
Time frame: change from take chinese herb in one week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Stable Coronary Artery Disease, run by First Teaching Hospital of Tianjin University of Traditional Chinese Medicine at 32 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact bi mr yingfei, doctor (022-27432327, yingfei1981@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EuroQol-5 Dimensions (EQ-5D) (time frame: change from take chinese herb in one week). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2017.