Chronic Stable Angina PectorisNCT04244812

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

A study testing Moxibustion and Laser doppler flowmetry in people with Chronic Stable Angina Pectoris, run by Zhejiang Chinese Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 20 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Chronic Stable Angina Pectoris
What is being tested?: Moxibustion and Laser doppler flowmetry
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteChina
Study dates: Feb 2020to 31 Dec 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

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;

Show all 11Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Yongliang Jiang, M.D contact

Hantong Hu contact

China1 site

the Third affiliated hospital of Zhejiang Chinese Medical university
Hanzhou, Zhejiang, 310000
Hantong Hu, 86-18667103032, 413351308@qq.com
Xiaoyu Li, 86-15017541803, 752616172@qq.com

Other trials in China

About this study

Read the 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.

Conditions: Chronic Stable Angina Pectoris
Being tested: Moxibustion, Laser doppler flowmetry
Keywords: meridians, acupuncture, chronic stable angina pectoris, meridian phenomena

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04244812
Study group	Role	What they receive
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 Receives: 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. Receives: 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. Receives: Other: Moxibustion; Device: Laser doppler flowmetry

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 202031 Dec 2021

First posted28 Jan 2020
Study startFeb 2020 (estimated)
Primary completion31 Dec 2020 (estimated)
Study completion31 Dec 2021 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Chronic Stable Angina PectorisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 120 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04244812
Sponsor's protocol ID: 2019ZY008-MERIDIAN
Status last verified: Jan 2020
First submitted: 21 Jan 2020
Last updated: 30 Jan 2020
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 18504639
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.
PubMed 19162851
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.
PubMed 17906382
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.
PubMed 24118419
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.
PubMed 32243379

Want to know more?

Yongliang Jiang, M.D

86-13858173136

jyl2182@126.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Stable Angina Pectoris trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Microcirculatory Characteristics of the Heart and Lung Meridians: A Study of CSAP Patients and Healthy Adults
ClinicalTrials.gov ID: NCT04244812
Acronym / sponsor ID: 2019ZY008-MERIDIAN
Conditions: Chronic Stable Angina Pectoris
Keywords: meridians, acupuncture, chronic stable angina pectoris, meridian phenomena
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 120 participants (estimated)
Lead sponsor: Zhejiang Chinese Medical UniversityOther government
Collaborators: The Third Affiliated hospital of Zhejiang Chinese Medical University, The First Affiliated Hospital of Zhejiang Chinese Medical University
Study start: Feb 2020 (estimated)
Primary completion: 31 Dec 2020 (estimated)
Study completion: 31 Dec 2021 (estimated)
First posted: 28 Jan 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
CSAP group	Other	Device: Laser doppler flowmetryParticipants 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 control group	Other	Device: Laser doppler flowmetryParticipants 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.
Healthy intervention group	Experimental	Other: Moxibustion, Device: Laser doppler flowmetryParticipants in the healthy intervention group will receive intervention of moxibustion in the Heart and Lung meridians.

Who may qualify

Ages: 20 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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;

Key exclusion criteria (11 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MoxibustionTwo 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.	Other	Healthy intervention group
Laser doppler flowmetryLaser doppler flowmetry will be used to detect the microcirculatory characteristics of meridian phenomena	Device	CSAP group, Healthy control group, Healthy intervention group

Primary outcome

Change from baseline blood flow curve
Time frame: 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
Change from baseline blood perfusion units
Time frame: 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

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2020.
Background: PubMed 18504639Hsiu 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.
Background: PubMed 19162851Hsiu 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.
Background: PubMed 17906382Hsiu 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.
Background: PubMed 24118419Hsiu 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.
Derived from this study: PubMed 32243379Hu 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.

Related trials for Chronic Stable Angina Pectoris

Active, not recruitingObservational study
REDUCER-I: An Observational Study of the Neovasc Reducer™ System
Angina Pectoris, Angina Pectoris, Stable
Active, not recruiting
SELUTION 4 De Novo Small Vessel IDE Trial
Coronary Artery Disease
Not yet recruiting
Drug-Coated Balloon Only Strategy After Recanalization of Chronic Total Coronary Occlusions
Angina (Stable), Coronary Occlusion
Not yet recruiting
BRIDGE Trial: Embedding Consumer-grade mHealth Technologies Into Cardiac Rehabilitation
Acute Myocardial Infarction (AMI), Percutaneous Coronary Intervention (PCI)
RecruitingObservational study
Advanced Invasive Diagnosis Strategy for Post-PCI Patients With Stable Coronary Syndromes Undergoing Coronary Angiography
Angina (Stable), Percutaneous Coronary Intervention (PCI)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yongliang Jiang, M.D contact

Hantong Hu contact

Jianqiao Fang, M.D principal investigator

Zhejiang Chinese Medical University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Moxibustion and Laser doppler flowmetry in people with Chronic Stable Angina Pectoris, run by Zhejiang Chinese Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yongliang Jiang, M.D (86-13858173136, jyl2182@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline blood flow curve (time frame: 5-minute baseline, 15 minutes during moxibustion and 5 minutes after stopping moxibustion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04244812, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2020.