Clinical trial NCT04244812: The Microcirculatory Characteristics of the Heart and Lung Meridians: A Study of CSAP Patients and Healthy Adults
Official title: The Microcirculatory Characteristics of the Heart and Lung Meridians: A Study of CSAP Patients and Healthy Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Stable Angina Pectoris
Keywords: meridians
acupuncture
chronic stable angina pectoris
meridian phenomena
Lead sponsor: Zhejiang Chinese Medical University
Sponsor class: OTHER_GOV
Collaborators: name: The Third Affiliated hospital of Zhejiang Chinese Medical University
name: The First Affiliated Hospital of Zhejiang Chinese Medical University
First posted: 2020-01-28
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline blood flow curve
timeFrame: 5-minute baseline, 15 minutes during moxibustion and 5 minutes after stopping moxibustion
measure: Change from baseline blood perfusion units
timeFrame: 5-minute baseline, 15 minutes during moxibustion and 5 minutes after stopping moxibustion
Secondary outcomes:
Other outcomes:
Locations:
city: Hanzhou
country: China
facility: the Third affiliated hospital of Zhejiang Chinese Medical university
state: Zhejiang
Study officials:
affiliation: Zhejiang Chinese Medical University
name: Jianqiao Fang, M.D
role: PRINCIPAL_INVESTIGATOR
References:
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.
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. Annu Int Conf IEEE Eng Med Biol Soc. 2008;2008:1084-6. doi: 10.1109/IEMBS.2008.4649348.
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. doi: 10.1088/0967-3334/28/10/N01. Epub 2007 Sep 18.
citation: Hsiu H, Hsu WC, Wu YF, Hsu CL, Chen CY. Differences in the skin-surface laser Doppler signals between polycystic ovary syndrome and normal subjects. Microcirculation. 2014 Feb;21(2):124-30. doi: 10.1111/micc.12095.
citation: Hu H, Jiang Y, Li X, Lou J, Zhang Y, He X, Fang J, Wu Y, Shao X, Fang J. The microcirculatory characteristics of the heart and lung meridians: Study protocol clinical trial (SPIRIT Compliant). Medicine (Baltimore). 2020 Apr;99(14):e19594. doi: 10.1097/MD.0000000000019594.