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

Sponsor
Zhejiang Chinese Medical University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04244812
Collaborator
The Third Affiliated hospital of Zhejiang Chinese Medical University (Other), The First Affiliated Hospital of Zhejiang Chinese Medical University (Other)
120
1
3
23
5.2

Study Details

Study Description

Brief Summary

This study is designed to detect the microcirculatory characteristics of meridian phenomena by using an objective assessment tool and investigate the site specificity for the meridian-visceral association and surface-surface association between two specific meridians.

Condition or Disease Intervention/Treatment Phase
  • Other: Moxibustion
  • Device: Laser doppler flowmetry
N/A

Detailed Description

The Lung and Heart meridians are chosen as two specific studied meridians. Participants of chronic stable angina pectoris (CSAP) and healthy volunteers will be enrolled.

120 participants will be included and divided into the healthy control group, chronic stable angina pectoris (CSAP) group and healthy intervention group. Laser doppler flowmetry (LDF) will be used to assess the microcirculatory characteristics of meridian phenomena for the Heart and Lung meridians. The site specificity for the meridian-visceral association will be investigated by comparing the microcirculatory difference between the Heart and Lung meridians in the healthy control group and CSAP group. Besides, participants in the healthy intervention group will receive two sessions of moxibustion in the Heart meridian and Lung meridian respectively to explore the site specificity for the surface-surface association.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
The Microcirculatory Characteristics of the Heart and Lung Meridians: A Study of CSAP Patients and Healthy Adults
Anticipated Study Start Date :
Feb 1, 2020
Anticipated Primary Completion Date :
Dec 31, 2020
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Other: CSAP group

Participants in the CSAP group will receive examination of laser doppler flowmetry(LDF). The LDF probes will be left at 4 measuring acupoints, which include Shenmen (HT7) and Shaohai (HT3) of the Heart meridian, Taiyuan (LU9) and Chize (LU5) of the Lung meridian

Device: Laser doppler flowmetry
Laser doppler flowmetry will be used to detect the microcirculatory characteristics of meridian phenomena

Other: Healthy control group

Participants in the healthy control group will receive examination of laser doppler flowmetry(LDF). The LDF probes will be left at 4 measuring acupoints, which include Shenmen (HT7) and Shaohai (HT3) of the Heart meridian, Taiyuan (LU9) and Chize (LU5) of the Lung meridian.

Device: Laser doppler flowmetry
Laser doppler flowmetry will be used to detect the microcirculatory characteristics of meridian phenomena

Experimental: Healthy intervention group

Participants in the healthy intervention group will receive intervention of moxibustion in the Heart and Lung meridians.

Other: Moxibustion
Two sessions of moxibustion will be performed in the Heart meridian and Lung meridian successively. Intervention in the Heart meridian: moxibustion will be performed above Shaohai (HT3) for 15 minutes. During moxibustion, the probes of laser doppler flowmetry will detect the microcirculatory characteristics of three measuring sites, which include the midpoint of the Heart meridian along the left forearm, Chize (LU5) of the Lung meridian, and the midpoint of the Lung meridian along the left forearm. Intervention in the Lung meridian: moxibustion will be performed above Chize (LU5) for 15 minutes. During moxibustion, the probes of laser doppler flowmetry will detect the microcirculatory characteristics of three measuring sites, which include the midpoint of the Lung meridian along the left forearm, Shaohai (HT3) of the Heart meridian, and the midpoint of the Heart meridian along the left forearm.

Device: Laser doppler flowmetry
Laser doppler flowmetry will be used to detect the microcirculatory characteristics of meridian phenomena

Outcome Measures

Primary Outcome Measures

  1. Change from baseline blood flow curve [5-minute baseline, 15 minutes during moxibustion and 5 minutes after stopping moxibustion]

    Laser doppler flowmetry is used to assess blood flow curve of relevant sites along the Heart and Lung meridians

  2. Change from baseline blood perfusion units [5-minute baseline, 15 minutes during moxibustion and 5 minutes after stopping moxibustion]

    Laser doppler flowmetry is used to assess blood perfusion units of relevant sites along the Heart and Lung meridians

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

Inclusion criteria for the CSAP group

  • 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 health volunteers

  • Healthy volunteers should provide a recent medical examination report to confirm they have not any cardiovascular, respiratory, digestive, urinary, hematological, endocrine and neurological 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 informed consent is provided by themselves or their lineal kin.

Exclusion Criteria:

Exclusion criteria for the CSAP group

  • Patients with 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 conditions of lung diseases, such as obstructive pulmonary disease;

  • 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 health volunteers

  • Participants have mental illness, severe depression, alcohol dependence or history of drug abuse;

  • Pregnant or lactating participants ;

  • Participants are participating in other trials.

Contacts and Locations

Locations

Site City State Country Postal Code
1 the Third affiliated hospital of Zhejiang Chinese Medical university Hanzhou Zhejiang China 310000

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Jianqiao Fang, M.D, Zhejiang Chinese Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Jianqiao Fang, President, Zhejiang Chinese Medical University
ClinicalTrials.gov Identifier:
NCT04244812
Other Study ID Numbers:
  • 2019ZY008-MERIDIAN
First Posted:
Jan 28, 2020
Last Update Posted:
Jan 30, 2020
Last Verified:
Jan 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jianqiao Fang, President, Zhejiang Chinese Medical University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 30, 2020