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

January 21, 2020 updated by: Jianqiao Fang, Zhejiang Chinese Medical University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

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

Study Contact

  • Name: Yongliang Jiang
  • Phone Number: 86-13858173136
  • Email: jyl2182@126.com

Study Locations

  • China
    • Zhejiang
      • Hanzhou, Zhejiang, China, 310000
        • Recruiting
        • the Third Affiliated Hospital of Zhejiang Chinese Medical University

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

40 patients with chronic stable angina pectoris (CSAP) and 40 healthy volunteer.

Description

Inclusion Criteria:

Inclusion criteria for CSAP

  1. 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);
  2. Patients should meet the diagnostic criteria of CSAP and the Canadian Cardiovascular Society(CCS) classification for CSAP is level II or III;
  3. The medical history of angina pectoris ≥3 months, with at least 2 episodes per week in the last month;
  4. 35 ≤ age ≤65 years, male or female;
  5. Patients have clear consciousness and could communicate with others normally;
  6. 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

  1. 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;
  2. 35 ≤ age ≤65 years, male or female;
  3. Participants have clear consciousness and could communicate with others normally;
  4. Participants could understand the full study protocol and have high adherence .Written informed consent is signed by themselves or their lineal kin.

Exclusion Criteria:

Exclusion criteria for CSAP

  1. 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);
  2. Patients' chest pain is caused by valvular heart disease, hypertrophic cardiomyopathy and dilated cardiomyopathy;
  3. Patients' chest pain is caused by non-cardiac disease (such as severe neurosis, climacteric syndrome, cervical spondylosis, and esophageal/pulmonary/chest wall lesions);
  4. Patients have concomitant conditions of lung diseases, such as chronic obstructive pulmonary disease (COPD);
  5. Patients have serious concomitant conditions and and fail to treat them effectively, such as diseases of the digestive, urinary, respiratory, hematological and nervous system;
  6. Patients have mental illness, severe depression, alcohol dependence or history of drug abuse;
  7. Pregnant or lactating patients;
  8. Patients are participating in other trials.

Exclusion criteria of health volunteers

  1. Participants have sudden severe diseases during the trial, such as cardiovascular diseases, liver diseases, kidney diseases, urinary diseases and hematological diseases.
  2. Participants have mental illness, severe depression, alcohol dependence or history of drug abuse;
  3. Pregnant or lactating participants ;
  4. Participants are participating in other trials.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CSAP group
This group will include 40 patients with chronic stable angina pectoris (CSAP).
Device: Infrared thermal imaging

Infrared thermal imaging will be adopted to assess the heat transport characteristics of meridian phenomenon for participants in the two groups.

  1. Experimental device: a NEC InfRec R450 infrared thermal imaging camera
  2. Experimental process: The participants will be allowed to stabilize for 15 minutes in a supine position in the experimental room before formal examination They are asked to keep silent, breathe normally and avoid movement of limbs during the whole measuring period. The height and angle of the infrared thermal imaging camera is adjusted so that the measurement sites of the participant's arm is located in the center of the camera screen. The infrared thermal imaging and acupoint temperature will be recorded for 5 minutes.
  3. Measurement sites: Shenmen (HT7) and Shaohai (HT3) of the Heart meridian, Taiyuan(LU9) and Chize (LU5) of the Lung meridian.
Healthy group
This group will include 40 healthy volunteers.
Device: Infrared thermal imaging

Infrared thermal imaging will be adopted to assess the heat transport characteristics of meridian phenomenon for participants in the two groups.

  1. Experimental device: a NEC InfRec R450 infrared thermal imaging camera
  2. Experimental process: The participants will be allowed to stabilize for 15 minutes in a supine position in the experimental room before formal examination They are asked to keep silent, breathe normally and avoid movement of limbs during the whole measuring period. The height and angle of the infrared thermal imaging camera is adjusted so that the measurement sites of the participant's arm is located in the center of the camera screen. The infrared thermal imaging and acupoint temperature will be recorded for 5 minutes.
  3. Measurement sites: Shenmen (HT7) and Shaohai (HT3) of the Heart meridian, Taiyuan(LU9) and Chize (LU5) of the Lung meridian.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infrared thermal images
Time Frame: 5 minutes
Infrared thermal images could reflect the heat transport characteristics of meridian phenomenon.
5 minutes
Acupoint temperature
Time Frame: 5 minutes
Acupoint temperature could reflect the heat transport characteristics of meridian phenomenon.
5 minutes

Collaborators and Investigators

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

Sponsor

Zhejiang Chinese Medical University

Collaborators

The Third Affiliated hospital of Zhejiang Chinese Medical University
The First Affiliated Hospital of Zhejiang Chinese Medical University

Investigators

  • Principal Investigator: Jianqiao Fang, Zhejiang Chinese Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

February 1, 2020

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

August 1, 2019

First Submitted That Met QC Criteria

August 2, 2019

First Posted (Actual)

August 6, 2019

Study Record Updates

Last Update Posted (Actual)

January 22, 2020

Last Update Submitted That Met QC Criteria

January 21, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019ZY003-MERIDIAN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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