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

NCT ID: NCT04264559

Last Updated: 2020-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-31

Study Completion Date

2021-12-31

Brief Summary

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Although some important progresses were made in the field of the meridian research, no breakthroughs have been achieved. Besides,there are some problems in meridian researches. Particularly, previous research of meridian phenomena involved lots of subjective elements and outcomes.Researches that use modern scientific techniques to investigate the biological characteristics of meridian phenomenon are urgently needed. Therefore, this study is designed to assess the heat transport characteristics of the Heart and Lung meridians by infrared thermal imaging (ITI). Thus, the biological characteristics of meridian phenomena could be presented objectively in a scientific methodology

Detailed Description

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This study will include 40 patients with chronic stable angina pectoris (CSAP), and 80 healthy adults. Infrared thermal imaging (ITI) examination will be adopted to assess the heat transport characteristics of the Heart and Lung meridians and investigate the specificity for the meridian-visceral correlation and site-to-site correlation between two specific meridians.

Conditions

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Chronic Stable Angina Pectoris

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Healthy control group

This group will include 40 healthy adults.

Group Type OTHER

Infrared thermal imaging

Intervention Type DIAGNOSTIC_TEST

A thermal imager is used to record thermal images.The baseline temperature of relevant acupoints or sites on the Heart and Lung meridians will be measured.

CSAP group

This study will include 40 patients with chronic stable angina pectoris (CSAP).

Group Type OTHER

Infrared thermal imaging

Intervention Type DIAGNOSTIC_TEST

A thermal imager is used to record thermal images.The baseline temperature of relevant acupoints or sites on the Heart and Lung meridians will be measured.

Healthy intervention group

This group will include 40 healthy adults. They will receive moxibustion intervention.

Group Type EXPERIMENTAL

Infrared thermal imaging

Intervention Type DIAGNOSTIC_TEST

A thermal imager is used to record thermal images.The baseline temperature of relevant acupoints or sites on the Heart and Lung meridians will be measured.

Moxibustion

Intervention Type PROCEDURE

Two sessions of moxibustion intervention will be performed in the Heart meridian and Lung meridian successively. During moxibustion, the temperature change of relevant acupoints or sites in the Heart and Lung meridians will be measured by infrared thermal imaging.

* Intervention in the Heart meridian: moxibustion will be performed in acupoint HT3 of the Heart meridian for 15 minutes.
* Intervention in the Lung meridian: moxibustion will be performed in acupoint LU5 of the Lung meridian for 15 minutes.

Interventions

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Infrared thermal imaging

A thermal imager is used to record thermal images.The baseline temperature of relevant acupoints or sites on the Heart and Lung meridians will be measured.

Intervention Type DIAGNOSTIC_TEST

Moxibustion

Two sessions of moxibustion intervention will be performed in the Heart meridian and Lung meridian successively. During moxibustion, the temperature change of relevant acupoints or sites in the Heart and Lung meridians will be measured by infrared thermal imaging.

* Intervention in the Heart meridian: moxibustion will be performed in acupoint HT3 of the Heart meridian for 15 minutes.
* Intervention in the Lung meridian: moxibustion will be performed in acupoint LU5 of the Lung meridian for 15 minutes.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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.


* Healthy volunteers who could provide a recent medical examination report to confirm they have not any cardiovascular and respiratory 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 consent is signed.

Exclusion Criteria

* Patients have 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 lung diseases;
* 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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The First Affiliated Hospital of Zhejiang Chinese Medical University

OTHER

Sponsor Role collaborator

Zhejiang Chinese Medical University

OTHER_GOV

Sponsor Role lead

Responsible Party

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Jianqiao Fang

President

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jianqiao Fang

Role: PRINCIPAL_INVESTIGATOR

Zhejiang Chinese Medical University

Locations

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the Third affiliated hospital of Zhejiang Chinese Medical university

Hanzhou, Zhejiang, China

Site Status

Countries

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China

Central Contacts

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Yongliang Jiang

Role: CONTACT

86-13858173136

Facility Contacts

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Hantong Hu

Role: primary

86-18667103032

Xiaoyu Li

Role: backup

86-15017541803

Other Identifiers

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2019ZY009-MERIDIAN

Identifier Type: -

Identifier Source: org_study_id

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