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

Chronic Stable Angina Pectoris Clinical Trial

Official title:

A Study on the Microcirculatory 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: NCT04041206
• Other study ID #: 2019ZY001-MERIDIAN
• Status: Recruiting
• Start date: June 1, 2019
• Est. completion date: December 2021

Study information

• Verified date: August 2019
• Source: Zhejiang Chinese Medical University
• Contact: Yongliang Jiang, Ph.D
• 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 microcirculatory characteristics of meridian phenomenon for the Heart and Lung meridians by using laser doppler. 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. Laser doppler examination will be adopted to assess the microcirculatory characteristics of meridian phenomenon for Heart and Lung meridians in the physiology/pathological state. In addition, by comparing microcirculation in the acupoints along the Heart and Lung meridians, the relative specificity of the two meridians will also be investigated. Primary outcomes will be blood flow curve and blood perfusion units(PU). Furthermore, this study will build standardized techniques and schemes for detecting the microcirculatory 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
• Accepts healthy volunteers: Accepts Healthy Volunteers
• 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 Stable Angina Pectoris

Intervention

Device:
• Laser doppler
Laser doppler will be adopted to assess the microcirculatory characteristics of meridian phenomenon for participants in the two groups. Experimental device: Four-channel laser doppler flowmetry (PeriFlux System 5000, Sweden). 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 and normal breath and avoid limb movement during the whole measuring period. The probes will be left at 4 measuring sites. Blood flow curve will be recorded constantly using Perisoft software (PeriFlux, Sweden). Microcirculatory flux in the measuring sites will be calculated [Perfusion units (PU) =concentration of moving blood cells (CMBC)×velocity (V)]. The acupoint microcirculation 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 (9)

Bernard F, Vinet A, Verdant C. Skin microcirculation and vasopressin infusion: a laser Doppler study. Crit Care. 2006;10(2):135. Review. — View Citation

Hsiu H, Hsu WC, Chen BH, Hsu CL. Differences in the microcirculatory effects of local skin surface contact pressure stimulation between acupoints and nonacupoints: possible relevance to acupressure. Physiol Meas. 2010 Jun;31(6):829-41. doi: 10.1088/0967-3334/31/6/007. Epub 2010 May 18. — View Citation

Hsiu H, Hsu WC, Hsu CL, Huang SM, Jan MY, Wang WK, Wang YY. Spectral analysis on the microcirculatory laser Doppler signal at the acupuncture point. Conf Proc IEEE Eng Med Biol Soc. 2008;2008:1084-6. doi: 10.1109/IEMBS.2008.4649348. — View Citation

Hsiu H, Hsu WC, Hsu CL, Huang SM, Lin YY. Microcirculatory changes by laser Doppler after infrared heating over acupuncture points--relevance to moxibustion. Photomed Laser Surg. 2009 Dec;27(6):855-61. doi: 10.1089/pho.2008.2390. — View Citation

Hsiu H, Hsu WC, Huang SM, Hsu CL, Lin Wang YY. Spectral analysis of the microcirculatory laser Doppler signal at the Hoku acupuncture point. Lasers Med Sci. 2009 May;24(3):353-8. doi: 10.1007/s10103-008-0569-8. Epub 2008 May 27. — View Citation

Hsiu H, Huang SM, Chao PT, Hsu WC, Hsu CL, Jan MY, Wang WK, Wang YY. Study on the microcirculatory blood velocity of acupoint monitored by laser Doppler signal. Conf Proc IEEE Eng Med Biol Soc. 2007;2007:959-62. — View Citation

Hsiu H, Huang SM, Chao PT, Jan MY, Hsu TL, Wang WK, Wang YY. Microcirculatory characteristics of acupuncture points obtained by laser Doppler flowmetry. Physiol Meas. 2007 Oct;28(10):N77-86. Epub 2007 Sep 18. — View Citation

Huang T, Wang RH, Zhang WB, Han B, Wang GJ, Tian YY, Zhang YQ. The influence of different methods of acupuncture on skin surface perfusion. J Tradit Chin Med. 2012 Mar;32(1):40-4. — View Citation

Litscher G, Wang L, Huber E, Nilsson G. Changed skin blood perfusion in the fingertip following acupuncture needle introduction as evaluated by laser Doppler perfusion imaging. Lasers Med Sci. 2002;17(1):19-25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood flow curve	The blood flow curve could reflect the microcirculatory flux in the measuring sites	5 minutes
Primary	Blood perfusion units	Perfusion units (PU)=concentration of moving blood cells (CMBC)×velocity (V)	5 minutes

External Links

•   Laterality and coherence analysis of Laser Doppler Flowmetry signals in bilateral Nèi guan (?? PC 6): a potential non-invasive method to assess microcirculatory changes of people in different ages