NCT04244812

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 28, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

January 30, 2020

Status Verified

January 1, 2020

Enrollment Period

11 months

First QC Date

January 21, 2020

Last Update Submit

January 29, 2020

Conditions

Chronic Stable Angina Pectoris

Keywords

meridiansacupuncturechronic stable angina pectorismeridian phenomena

Outcome Measures

Primary Outcomes (2)

  • Change from baseline blood flow curve

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

    5-minute baseline, 15 minutes during moxibustion and 5 minutes after stopping moxibustion

  • Change from baseline blood perfusion units

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

    5-minute baseline, 15 minutes during moxibustion and 5 minutes after stopping moxibustion

Study Arms (3)

CSAP group

OTHER

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

Healthy control group

OTHER

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

Healthy intervention group

EXPERIMENTAL

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

Other: MoxibustionDevice: Laser doppler flowmetry

Interventions

MoxibustionOTHER

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.

Healthy intervention group
Laser doppler flowmetryDEVICE

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

CSAP groupHealthy control groupHealthy intervention group

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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 CSAP is more than 3 months with attacks occurring at least twice weekly in the last month;
  • ≤ 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.
  • 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.

You may not qualify if:

  • 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.
  • Participants have mental illness, severe depression, alcohol dependence or history of drug abuse;
  • Pregnant or lactating participants ;
  • Participants are participating in other trials.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Third affiliated hospital of Zhejiang Chinese Medical university

Hanzhou, Zhejiang, 310000, China

Location

Related Publications (5)

  • 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: 18504639BACKGROUND

  • 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: 19162851BACKGROUND

  • 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: 17906382BACKGROUND

  • 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.

    PMID: 24118419BACKGROUND

  • 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.

    PMID: 32243379DERIVED

MeSH Terms

Interventions

MoxibustionLaser-Doppler Flowmetry

Intervention Hierarchy (Ancestors)

Acupuncture TherapyComplementary TherapiesTherapeuticsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRheologyInvestigative Techniques

Study Officials

  • Jianqiao Fang, M.D

    Zhejiang Chinese Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yongliang Jiang, M.D

CONTACT

86-13858173136jyl2182@126.com

Hantong Hu

CONTACT

86-18667103032413351308@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
President

Study Record Dates

First Submitted

January 21, 2020

First Posted

January 28, 2020

Study Start

February 1, 2020

Primary Completion

December 31, 2020

Study Completion

December 31, 2021

Last Updated

January 30, 2020

Record last verified: 2020-01

Locations

CN(1)