The Heat Transport Characteristics of the Heart and Lung Meridians: A Study of CSAP Patients and Healthy Adults

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 phenomena 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 the Heart and Lung meridians by infrared thermal imaging (ITI). Thus, the biological characteristics of meridian phenomena could be presented objectively in a scientific methodology

Study Overview

• Status: Unknown
• Conditions: Chronic Stable Angina Pectoris
• Intervention / Treatment: Diagnostic test: Infrared thermal imaging; Procedure: Moxibustion

Detailed Description

This study will include 40 patients with chronic stable angina pectoris (CSAP), and 80 healthy adults. Infrared thermal imaging (ITI) examination will be adopted to assess the heat transport characteristics of the Heart and Lung meridians and investigate the specificity for the meridian-visceral correlation and site-to-site correlation between two specific meridians.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

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

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Inclusion criteria for CSAP patients

• 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 CSAP is more than 3 months with attacks occurring at least twice weekly in the last month;
• 35≤age ≤75 years, male or female;
• Patients have clear consciousness and could communicate with others normally;
• Patients could understand the full study protocol and written informed consent is signed.

Inclusion criteria for healthy adults

• Healthy volunteers who could provide a recent medical examination report to confirm they have not any cardiovascular and respiratory disease;
• age≥20 years, male or female;
• Participants have clear consciousness and could communicate with others normally;
• Participants could understand the full study protocol and written consent is signed.

Exclusion Criteria:

Exclusion criteria for CSAP patients

• Patients have acute coronary syndrome and severe arrhythmias;
• Patients' chest pain is caused by valvular heart disease, hypertrophic cardiomyopathy and dilated cardiomyopathy;
• Patients' chest pain is caused by non-cardiac disease;
• Patients have concomitant lung diseases;
• Patients have serious concomitant conditions 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 for healthy adults

• Participants have mental illness, severe depression, alcohol dependence or history of drug abuse;
• Pregnant or lactating participants ;
• Participants are participating in other trials.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Healthy control group; This group will include 40 healthy adults.	Diagnostic test: Infrared thermal imaging; A thermal imager is used to record thermal images.The baseline temperature of relevant acupoints or sites on the Heart and Lung meridians will be measured.
Other: CSAP group; This study will include 40 patients with chronic stable angina pectoris (CSAP).	Diagnostic test: Infrared thermal imaging; A thermal imager is used to record thermal images.The baseline temperature of relevant acupoints or sites on the Heart and Lung meridians will be measured.
Experimental: Healthy intervention group; This group will include 40 healthy adults. They will receive moxibustion intervention.	Diagnostic test: Infrared thermal imaging; A thermal imager is used to record thermal images.The baseline temperature of relevant acupoints or sites on the Heart and Lung meridians will be measured.; Procedure: Moxibustion; Two sessions of moxibustion intervention will be performed in the Heart meridian and Lung meridian successively. During moxibustion, the temperature change of relevant acupoints or sites in the Heart and Lung meridians will be measured by infrared thermal imaging.; Intervention in the Heart meridian: moxibustion will be performed in acupoint HT3 of the Heart meridian for 15 minutes.; Intervention in the Lung meridian: moxibustion will be performed in acupoint LU5 of the Lung meridian for 15 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Temperature change of relevant acupoints or sites	Infrared thermal imaging examination is used to assess temperature change of relevant acupoints or sites of the Heart and Lung meridians	Baseline, 15 minutes during moxibustion, 5 minutes after stopping moxibustion.

Collaborators and Investigators

• Sponsor: Zhejiang Chinese Medical University
• Collaborators: The First Affiliated Hospital of Zhejiang Chinese Medical University
• Investigators: Principal Investigator: Jianqiao Fang, Zhejiang Chinese Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2020
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: February 8, 2020
• First Submitted That Met QC Criteria: February 8, 2020
• First Posted (Actual): February 11, 2020

Study Record Updates

• Last Update Posted (Actual): February 11, 2020
• Last Update Submitted That Met QC Criteria: February 8, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: stable angina pectoris; meridian; infrared thermal imaging
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina Pectoris; Angina, Stable
• Other Study ID Numbers: 2019ZY009-MERIDIAN

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No