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Clinical Trials/NCT04046640
NCT04046640
Unknown
Not Applicable

A Study on the Heat Transport Characteristics of Meridian Phenomenon for the Heart and Lung Meridians Based on Patients With Stable Angina Pectoris

Zhejiang Chinese Medical University1 site in 1 country80 target enrollmentFebruary 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease
Sponsor
Zhejiang Chinese Medical University
Enrollment
80
Locations
1
Primary Endpoint
Acupoint temperature
Last Updated
6 years ago

Overview

Brief Summary

Although some important progresses were made in the field of the meridian research, no breakthroughs have been achieved. Besides,there are some problems in meridian researches. Particularly, previous research of meridian phenomenon involved lots of subjective elements and outcomes.Researches that use modern scientific techniques to investigate the biological characteristics of meridian phenomenon are urgently needed. Therefore, this study is designed to assess the heat transport characteristics of meridian phenomenon for the Heart and Lung meridians by using infrared thermal imaging. Thus, the biological characteristics of meridian phenomenon could be presented objectively in a scientific methodology.

Detailed Description

This study will include 40 patients diagnosed with chronic stable angina pectoris (CSAP) and 40 healthy volunteers. Infrared thermal imaging will be adopted to assess the heat transport characteristics of meridian phenomenon for Heart and Lung meridians in the physiology/pathological state. In addition, by comparing the heat transport characteristics in the acupoints along the Heart and Lung meridians, the relative specificity of the two meridians will also be investigated. Primary outcomes will be infrared thermal images and acupoint temperature. Furthermore, this study will build standardized techniques and schemes for detecting the heat transport characteristics of meridian phenomenon for Heart and Lung. The results of this study could also provide scientific foundation for traditional meridian theories.

Registry
clinicaltrials.gov
Start Date
February 2020
End Date
December 2021
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Zhejiang Chinese Medical University
Responsible Party
Principal Investigator
Principal Investigator

Jianqiao Fang

President

Zhejiang Chinese Medical University

Eligibility Criteria

Inclusion Criteria

  • Inclusion criteria for CSAP
  • Patients should meet the diagnostic criteria of coronary heart disease, which includes the following items: 1)confirmed old myocardial infarction (MI), or a history of percutaneous coronary intervention(PCI), or coronary artery bypass grafting; 2)50% or more luminal stenosis in at least one coronary artery or major branch segment confirmed by coronary angiogram or CT angiography; 3) myocardial ischemia indicted by exercise stress radionuclide myocardial imaging; 4) treadmill exercise testing is positive (for male patients);
  • Patients should meet the diagnostic criteria of CSAP and the Canadian Cardiovascular Society(CCS) classification for CSAP is level II or III;
  • The medical history of angina pectoris ≥3 months, with at least 2 episodes per week in the last month;
  • 35 ≤ age ≤65 years, male or female;
  • Patients have clear consciousness and could communicate with others normally;
  • Patients could understand the full study protocol and have high adherence. Written informed consent is signed by themselves or their lineal kin.
  • Inclusion criteria for health volunteers
  • Healthy volunteers who could provide a recent (in the past 3 month) medical examination report to confirm they have not any cardiovascular, respiratory, digestive, urinary, hematological, endocrine and neurological disease;
  • 35 ≤ age ≤65 years, male or female;

Exclusion Criteria

  • Exclusion criteria for CSAP
  • Patients with acute coronary syndrome (including acute myocardial infarction and unstable angina) and severe arrhythmias (such as severe atrioventricular block, ventricular tachycardia, supraventricular tachycardia, frequent premature beats and premature ventricular contraction);
  • Patients' chest pain is caused by valvular heart disease, hypertrophic cardiomyopathy and dilated cardiomyopathy;
  • Patients' chest pain is caused by non-cardiac disease (such as severe neurosis, climacteric syndrome, cervical spondylosis, and esophageal/pulmonary/chest wall lesions);
  • Patients have concomitant conditions of lung diseases, such as chronic obstructive pulmonary disease (COPD);
  • Patients have serious concomitant conditions and and fail to treat them effectively, such as diseases of the digestive, urinary, respiratory, hematological and nervous system;
  • Patients have mental illness, severe depression, alcohol dependence or history of drug abuse;
  • Pregnant or lactating patients;
  • Patients are participating in other trials.
  • Exclusion criteria of health volunteers

Outcomes

Primary Outcomes

Acupoint temperature

Time Frame: 5 minutes

Acupoint temperature could reflect the heat transport characteristics of meridian phenomenon.

Infrared thermal images

Time Frame: 5 minutes

Infrared thermal images could reflect the heat transport characteristics of meridian phenomenon.

Study Sites (1)

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