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Innovation Research of Differentiation and Treatment Methods Based on CHD Phlegm and Blood Stasis Syndrome

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ClinicalTrials.gov Identifier: NCT02967718
Recruitment Status : Unknown
Verified November 2016 by Jingqing Hu, China Academy of Chinese Medical Sciences.
Recruitment status was:  Recruiting
First Posted : November 18, 2016
Last Update Posted : November 22, 2016
Sponsor:
Information provided by (Responsible Party):
Jingqing Hu, China Academy of Chinese Medical Sciences

Brief 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. 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.

Condition or disease
Coronary Heart Disease

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.

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Study Type : Observational
Estimated Enrollment : 13000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Clinical Observation of CHD Phlegm and Blood-stasis Syndrome Patients
Study Start Date : September 2016
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : December 2017

Group/Cohort
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



Primary Outcome Measures :
  1. all cause mortality [ Time Frame: 6 months ]

Biospecimen Retention:   Samples Without DNA
serum sample


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

  • Healthy or metabolism syndrome people
  • Clinical diagnosis of CHD stable stage or acute coronary disease or CHD heart failure

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02967718


Contacts
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Contact: Weiming Xu, Doctor 86-15652608470 dreameng2008@126.com

Locations
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China, Beijing
The First Integrative Hospital of Beijing Recruiting
Beijin, Beijing, China
Contact: Yanhui Wang    86-15810821765    yhuiwang@126.com   
Sponsors and Collaborators
Jingqing Hu

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Responsible Party: Jingqing Hu, Director of Institute of Basic Theory of Traditional Chinese Medicine, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT02967718     History of Changes
Other Study ID Numbers: 2014CB542903
First Posted: November 18, 2016    Key Record Dates
Last Update Posted: November 22, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Blind Loop Syndrome
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases