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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04046640
• Other study ID #: 2019ZY003-MERIDIAN
• Status: Recruiting
• Start date: February 2020
• Est. completion date: December 2021

Study information

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

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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2021
• Est. primary completion date: December 2020
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable
• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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. Experimental device: a NEC InfRec R450 infrared thermal imaging camera 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. Measurement sites: Shenmen (HT7) and Shaohai (HT3) of the Heart meridian, Taiyuan(LU9) and Chize (LU5) of the Lung meridian.

Locations

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

Sponsors (3)

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

Country where clinical trial is conducted

China, 

References & Publications (8)

Álvarez-Prats D, Carvajal-Fernández O, Valera Garrido F, Pecos-Martín D, García-Godino A, Santafe MM, Medina-Mirapeix F. Acupuncture Points and Perforating Cutaneous Vessels Identified Using Infrared Thermography: A Cross-Sectional Pilot Study. Evid Based Complement Alternat Med. 2019 Mar 21;2019:7126439. doi: 10.1155/2019/7126439. eCollection 2019. — View Citation

Cai W, Chen AW, Ding L, Shen WD. Thermal Effects of Acupuncture by the Infrared Thermography Test in Patients With Tinnitus. J Acupunct Meridian Stud. 2019 Aug;12(4):131-135. doi: 10.1016/j.jams.2019.05.002. Epub 2019 Jun 27. — View Citation

de Souza RC, Pansini M, Arruda G, Valente C, Brioschi ML. Laser acupuncture causes thermal changes in small intestine meridian pathway. Lasers Med Sci. 2016 Nov;31(8):1645-1649. Epub 2016 Aug 5. — View Citation

Fu Y, Ni JX, Marmori F, Zhu Q, Tan C, Zhao JP. Infrared thermal imaging-based research on the intermediate structures of the lung and large intestine exterior-interior relationship in asthma patients. Chin J Integr Med. 2016 Nov;22(11):855-860. Epub 2016 Jun 9. — View Citation

Kang J, Lee N, Ahn Y, Lee H. Study on improving blood flow with Korean red ginseng substances using digital infrared thermal imaging and Doppler sonography: randomized, double blind, placebo-controlled clinical trial with parallel design. J Tradit Chin Med. 2013 Feb;33(1):39-45. — View Citation

Lin M, Wei H, Zhao L, Zhao J, Cheng K, Deng H, Shen X, Zhang H. [Review on infrared temperature characteristics of acupoints in recent 10 years]. Zhongguo Zhen Jiu. 2017 Apr 12;37(4):453-456. doi: 10.13703/j.0255-2930.2017.04.028. Review. Chinese. — View Citation

Yang H, Park H, Lim C, Park S, Lee K. Infrared thermal imaging in patients with medial collateral ligament injury of the knee - a retrospective study. J Pharmacopuncture. 2014 Dec;17(4):50-4. doi: 10.3831/KPI.2014.17.036. — View Citation

Zheng J, Zhao Y, Wang Y, Hu S, Lu P, Shen X. The infrared radiation temperature characteristic of acupoints of mammary gland hyperplasia patients. Evid Based Complement Alternat Med. 2013;2013:567987. doi: 10.1155/2013/567987. Epub 2013 Nov 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infrared thermal images	Infrared thermal images could reflect the heat transport characteristics of meridian phenomenon.	5 minutes
Primary	Acupoint temperature	Acupoint temperature could reflect the heat transport characteristics of meridian phenomenon.	5 minutes