Coronary Heart DiseaseNCT02967718
Innovation Research of Differentiation and Treatment Methods Based on CHD Phlegm and Blood Stasis Syndrome
An observational study of Coronary Heart Disease, run by Jingqing Hu at 1 site in China.
Trial summary
Coronary heart disease is still the major cause of death in China. Chinese medicine plays more and more important role in CHD prevention and treatment. Phlegm and blood stasis are its major pathological basis. Read more about this study
- Who is it for?
- Ages 35 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Heart Disease
- How many people
- 13,000 participants
- Where
- 1 siteChina
- Study dates
- Sep 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 35 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy, metabolic or coronary heart disease people, whose age is between 35-85 years old, either female or male, without any inflammation, fever, trauma, burn or operation within 1 week.
Who may be able to join
- Healthy or metabolism syndrome people
- Clinical diagnosis of CHD stable stage or acute coronary disease or CHD heart failure
Who cannot join
- Any inflammation, fever, trauma, burn or operation within 1 week
- Obstructive pulmonary disease
- Cerebral vascular disease
- Severe renal or hepatic dysfunction
- Malignant neoplasms
- Hematopoietic system disease
- Sever mental disease
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Integrative Hospital of Beijing
Beijin, Beijing Municipality
Yanhui Wang, 86-15810821765, yhuiwang@126.com
About this study
Official title: Clinical Observation of CHD Phlegm and Blood-stasis Syndrome Patients
Coronary heart disease is still the major cause of death in China. Chinese medicine plays more and more important role in CHD prevention and treatment. Phlegm and blood stasis are its major pathological basis. Based on that, the investigator aims to evaluate the evolutionary process of CHD phlegm-blood stasis syndrome by large samples, multi-centre, cross-section observation combining with longitudinal tracking on-site survey method so as to guide the clinical treatment of CHD.
Read the detailed description
Coronary heart disease (CHD) is a major cause of myocardial infarct (MI) and death induced by atherosclerosis or coronary artery spasm. Despite improvements in interventional and pharmacological therapy for acute MI, the mortality early after AMI remains high. Nowadays, as our life quality develops and dietary structure changes, the morbidity of hyperlipidemia dramatically increased. Based on the Chinese medicine, hyperlipidemia belongs to phlegm and it's the basis of atherosclerosis, blood-stasis is the pathological basis of ischemia. Therefore, the investigator proposes that phlegm and blood-stasis syndrome is the main differentiation on CHD. Based on that, the investigator prospectively and retrospectively explores the evolutionary process of CHD phlegm-blood stasis syndrome by large samples, multi-centre, cross-section observation combining with longitudinal tracking on-site survey method.It will provide evidence and guidance to the future clinical treatment using Chinese medicine.
- Conditions
- Coronary Heart Disease
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control group | the healthy patients | |
| Metabolic syndrome group | Include patients who are accordance with diagnostic criteria of metabolic syndrome | |
| CHD stable stage group | Include patients who are accordance with diagnostic criteria of asymptomatic angina, stable angina or stable (more than 1 month) acute coronary syndrome | |
| Acute coronary syndrome group | Include patients who are accordance with diagnostic criteria of unstable angina or non-ST-segment elevated myocardial infarction | |
| PCI or CABG group | Include the patients who will undergo percutaneous coronary intervention of coronary artery bypass grafting | |
| CHD heart failure group | Include the patients who suffered heart failure cause by CHD |
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause mortality
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2016 (estimated)
- Study startSep 2016
- Primary completionMar 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart 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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 13,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jingqing Hu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jingqing Hu, China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02967718
- Sponsor's protocol ID
- 2014CB542903
- Status last verified
- Nov 2016
- First submitted
- 16 Nov 2016
- Last updated
- 22 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Wang J, Zhou C, Zhao Y, Hu J. Application of machine learning algorithms to predict heat-sensitive angina (HSA) attacks: a multicentric observational cohort study. Front Digit Health. 2026 Jul 21;8:1839307. doi: 10.3389/fdgth.2026.1839307. eCollection 2026.
PubMed 42553566Zhang J, Tong H, Jiang L, Hu J. Dietary Patterns Associated With Heat Retention in Blood Vessel Syndrome (HRBVS) in Coronary Heart Disease: A Cross-Sectional Study. Int J Gen Med. 2025 Mar 5;18:1283-1294. doi: 10.2147/IJGM.S510507. eCollection 2025.
PubMed 40062358
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Observation of CHD Phlegm and Blood-stasis Syndrome Patients
- ClinicalTrials.gov ID
- NCT02967718
- Acronym / sponsor ID
- 2014CB542903
- Conditions
- Coronary Heart Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 13,000 participants (estimated)
- Lead sponsor
- Jingqing HuUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 18 Nov 2016 (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.
Coronary heart disease is still the major cause of death in China. Chinese medicine plays more and more important role in CHD prevention and treatment. Phlegm and blood stasis are its major pathological basis. Based on that, the investigator aims to evaluate the evolutionary process of CHD phlegm-blood stasis syndrome by large samples, multi-centre, cross-section observation combining with longitudinal tracking on-site survey method so as to guide the clinical treatment of CHD.
Detailed description
Coronary heart disease (CHD) is a major cause of myocardial infarct (MI) and death induced by atherosclerosis or coronary artery spasm. Despite improvements in interventional and pharmacological therapy for acute MI, the mortality early after AMI remains high. Nowadays, as our life quality develops and dietary structure changes, the morbidity of hyperlipidemia dramatically increased. Based on the Chinese medicine, hyperlipidemia belongs to phlegm and it's the basis of atherosclerosis, blood-stasis is the pathological basis of ischemia. Therefore, the investigator proposes that phlegm and blood-stasis syndrome is the main differentiation on CHD. Based on that, the investigator prospectively and retrospectively explores the evolutionary process of CHD phlegm-blood stasis syndrome by large samples, multi-centre, cross-section observation combining with longitudinal tracking on-site survey method.It will provide evidence and guidance to the future clinical treatment using Chinese medicine.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Control group | – | –the healthy patients |
| Metabolic syndrome group | – | –Include patients who are accordance with diagnostic criteria of metabolic syndrome |
| CHD stable stage group | – | –Include patients who are accordance with diagnostic criteria of asymptomatic angina, stable angina or stable (more than 1 month) acute coronary syndrome |
| Acute coronary syndrome group | – | –Include patients who are accordance with diagnostic criteria of unstable angina or non-ST-segment elevated myocardial infarction |
| PCI or CABG group | – | –Include the patients who will undergo percutaneous coronary intervention of coronary artery bypass grafting |
| CHD heart failure group | – | –Include the patients who suffered heart failure cause by CHD |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy, metabolic or coronary heart disease people, whose age is between 35-85 years old, either female or male, without any inflammation, fever, trauma, burn or operation within 1 week.
Key inclusion criteria (2 listed)
- Healthy or metabolism syndrome people
- Clinical diagnosis of CHD stable stage or acute coronary disease or CHD heart failure
Key exclusion criteria (7 listed)
- Any inflammation, fever, trauma, burn or operation within 1 week
- Obstructive pulmonary disease
- Cerebral vascular disease
- Severe renal or hepatic dysfunction
- Malignant neoplasms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
all cause mortality
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2016.
- Derived from this study: PubMed 42553566Wang J, Zhou C, Zhao Y, Hu J. Application of machine learning algorithms to predict heat-sensitive angina (HSA) attacks: a multicentric observational cohort study. Front Digit Health. 2026 Jul 21;8:1839307. doi: 10.3389/fdgth.2026.1839307. eCollection 2026.
- Derived from this study: PubMed 40062358Zhang J, Tong H, Jiang L, Hu J. Dietary Patterns Associated With Heat Retention in Blood Vessel Syndrome (HRBVS) in Coronary Heart Disease: A Cross-Sectional Study. Int J Gen Med. 2025 Mar 5;18:1283-1294. doi: 10.2147/IJGM.S510507. eCollection 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Coronary Heart Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Heart Disease, run by Jingqing Hu at 1 site 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 2 inclusion and 7 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 22 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Weiming Xu, Doctor (86-15652608470, dreameng2008@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all cause mortality (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02967718, which also lists 2 linked publications.
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 22 Nov 2016.