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

November 20, 2016 updated by: Jingqing Hu

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

13000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

China
- Beijing
  - Beijin, Beijing, China
    - Recruiting
    - The First Integrative Hospital of Beijing
    - Contact:
      
      Yanhui Wang
      
      Phone Number: 86-15810821765
      
      Email: yhuiwang@126.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
all cause mortality Time Frame: 6 months	6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jingqing Hu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Anticipated)

March 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

November 16, 2016

First Submitted That Met QC Criteria