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

NCT04041206 | Unknown DMC

• 1 other identifier: 2019ZY001-MERIDIAN
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Stable Angina Pectoris

Keywords

meridians; acupuncture; chronic stable angina pectoris; meridian phenomenon; laser doppler

Outcome Measures

Primary Outcomes (2)

• Blood flow curve

  The blood flow curve could reflect the microcirculatory flux in the measuring sites

  5 minutes

• Blood perfusion units

  Perfusion units (PU)=concentration of moving blood cells (CMBC)×velocity (V)

  5 minutes

Study Arms (2)

CSAP group

This group will include 40 patients with chronic stable angina pectoris (CSAP).

Device: Laser doppler

Healthy group

This group will include 40 healthy volunteers.

Device: Laser doppler

Interventions

Laser doppler DEVICE

Laser doppler will be adopted to assess the microcirculatory characteristics of meridian phenomenon for participants in the two groups. 1. Experimental device: Four-channel laser doppler flowmetry (PeriFlux System 5000, Sweden). 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 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. 3. Measurement sites: Shenmen (HT7) and Shaohai (HT3) of the Heart meridian, Taiyuan(LU9) and Chize (LU5) of the Lung meridian

CSAP group; Healthy group

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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 angina pectoris ≥3 months, with at least 2 episodes per week in the last month;
• ≤ age ≤65 years, male or female;
• Patients have clear consciousness and could communicate with others normally;
• Patients could understand the full study protocol and have high adherence. Written informed consent is signed by themselves or their lineal kin.
• 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;
• ≤ age ≤65 years, male or female;
• Participants have clear consciousness and could communicate with others normally;
• Participants could understand the full study protocol and have high adherence .Written informed consent is signed by themselves or their lineal kin.

You may not qualify if:

• 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);
• Patients' chest pain is caused by valvular heart disease, hypertrophic cardiomyopathy and dilated cardiomyopathy;
• Patients' chest pain is caused by non-cardiac disease (such as severe neurosis, climacteric syndrome, cervical spondylosis, and esophageal/pulmonary/chest wall lesions);
• Patients have concomitant conditions of lung diseases, such as chronic obstructive pulmonary disease (COPD) ;
• Patients have serious concomitant conditions and 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.
• Participants have sudden severe diseases during the trial, such as cardiovascular diseases, liver diseases, kidney diseases, urinary diseases and hematological diseases.
• Participants have mental illness, severe depression, alcohol dependence or history of drug abuse;
• Pregnant or lactating participants ;
• Participants are participating in other trials.

Sponsors & Collaborators

• Zhejiang Chinese Medical University: lead
• The Third Affiliated hospital of Zhejiang Chinese Medical University: collaborator
• The First Affiliated Hospital of Zhejiang Chinese Medical University: collaborator

Study Sites (1)

the Third affiliated hospital of Zhejiang Chinese Medical university

Hanzhou, Zhejiang, 310000, China

RECRUITING

Related Publications (9)

• 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. doi: 10.1088/0967-3334/28/10/N01. Epub 2007 Sep 18.

  PMID: 17906382 BACKGROUND

• 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.

  PMID: 20479520 BACKGROUND

• 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. Annu Int Conf IEEE Eng Med Biol Soc. 2008;2008:1084-6. doi: 10.1109/IEMBS.2008.4649348.

  PMID: 19162851 BACKGROUND

• 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.

  PMID: 19698003 BACKGROUND

• 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. Annu Int Conf IEEE Eng Med Biol Soc. 2007;2007:959-62. doi: 10.1109/IEMBS.2007.4352451.

  PMID: 18002117 BACKGROUND

• Bernard F, Vinet A, Verdant C. Skin microcirculation and vasopressin infusion: a laser Doppler study. Crit Care. 2006;10(2):135. doi: 10.1186/cc4884.

  PMID: 16594988 BACKGROUND

• 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. doi: 10.1007/s10103-002-8262-9.

  PMID: 11845364 BACKGROUND

• 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.

  PMID: 18504639 BACKGROUND

• 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. doi: 10.1016/s0254-6272(12)60029-6.

  PMID: 22594100 BACKGROUND

MeSH Terms

Interventions

Laser-Doppler Flowmetry

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Rheology; Investigative Techniques

Study Officials

• Jianqiao Fang, Ph.D

  Zhejiang Chinese Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yongliang Jiang, Ph.D

CONTACT

86-13858173136; jyl2182@126.com

Hantong Hu, Ph.D

CONTACT

86-18667103032; 413351308@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President

Study Record Dates

• First Submitted: July 26, 2019
• First Posted: August 1, 2019
• Study Start: June 1, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: August 5, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)