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

Not Applicable

• Conditions: Chronic Stable Angina Pectoris
• Interventions: Device: Laser doppler flowmetry; Other: Moxibustion

• Registration Number: NCT04244812
• Lead Sponsor: Zhejiang Chinese Medical University

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.

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 Timeline

• Status Verified: 2020-01
• Study First Submitted: 2020-01-21
• Study First Submitted QC: 2020-01-27
• Study First Posted: 2020-01-28
• Last Update Submitted: 2020-01-29
• Last Update Posted: 2020-01-30
• Study Start: 2020-02
• Primary Completion: 2020-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CSAP group	Laser doppler flowmetry	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
Healthy intervention group	Moxibustion	Participants in the healthy intervention group will receive intervention of moxibustion in the Heart and Lung meridians.
Healthy intervention group	Laser doppler flowmetry	Participants in the healthy intervention group will receive intervention of moxibustion in the Heart and Lung meridians.
Healthy control group	Laser doppler flowmetry	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.

Primary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

the Third affiliated hospital of Zhejiang Chinese Medical university; 🇨🇳 Hanzhou, Zhejiang, China