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

Chronic Stable Angina Pectoris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04264559
• Other study ID #: 2019ZY009-MERIDIAN
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2020
• Est. completion date: December 2021

Study information

• Verified date: February 2020
• Source: Zhejiang Chinese Medical University
• Contact: Yongliang Jiang
• Phone: 86-13858173136
• Email: jyl2182[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable
• Chronic Stable Angina Pectoris

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.

Locations

Country	Name	City	State
China	the Third affiliated hospital of Zhejiang Chinese Medical university	Hanzhou	Zhejiang

Sponsors (2)

Lead Sponsor	Collaborator
Zhejiang Chinese Medical University	The First Affiliated Hospital of Zhejiang Chinese Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.