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

Coronary Heart Disease Clinical Trial

Official title:

Clinical Observation of CHD Phlegm and Blood-stasis Syndrome Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02967718
• Other study ID #: 2014CB542903
• Status: Recruiting
• Phase: N/A
• First received: November 16, 2016
• Last updated: November 20, 2016
• Start date: September 2016
• Est. completion date: December 2017

Study information

• Verified date: November 2016
• Source: China Academy of Chinese Medical Sciences
• Contact: Weiming Xu, Doctor
• Phone: 86-15652608470
• Email: dreameng2008[@]126.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 13000
• Est. completion date: December 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 85 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Blind Loop Syndrome
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Locations

Country	Name	City	State
China	The First Integrative Hospital of Beijing	Beijin	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jingqing Hu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all cause mortality		6 months	No