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

Primary Purpose

Chronic Stable Angina Pectoris

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Infrared thermal imaging
Moxibustion
Sponsored by
Zhejiang Chinese Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Stable Angina Pectoris focused on measuring stable angina pectoris, meridian, infrared thermal imaging

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Inclusion criteria for CSAP patients

  • 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 healthy adults

  • 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:

Exclusion criteria for CSAP patients

  • 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.

Exclusion criteria for healthy adults

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

Sites / Locations

  • the Third affiliated hospital of Zhejiang Chinese Medical university

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Experimental

Arm Label

Healthy control group

CSAP group

Healthy intervention group

Arm Description

This group will include 40 healthy adults.

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

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

Outcomes

Primary Outcome Measures

Temperature change of relevant acupoints or sites
Infrared thermal imaging examination is used to assess temperature change of relevant acupoints or sites of the Heart and Lung meridians

Secondary Outcome Measures

Full Information

First Posted
February 8, 2020
Last Updated
February 8, 2020
Sponsor
Zhejiang Chinese Medical University
Collaborators
The First Affiliated Hospital of Zhejiang Chinese Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04264559
Brief Title
The Heat Transport Characteristics of the Heart and Lung Meridians: A Study of CSAP Patients and Healthy Adults
Official Title
The Heat Transport Characteristics of the Heart and Lung Meridians: A Study of CSAP Patients and Healthy Adults
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 2020 (Anticipated)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhejiang Chinese Medical University
Collaborators
The First Affiliated Hospital of Zhejiang Chinese Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Stable Angina Pectoris
Keywords
stable angina pectoris, meridian, infrared thermal imaging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy control group
Arm Type
Other
Arm Description
This group will include 40 healthy adults.
Arm Title
CSAP group
Arm Type
Other
Arm Description
This study will include 40 patients with chronic stable angina pectoris (CSAP).
Arm Title
Healthy intervention group
Arm Type
Experimental
Arm Description
This group will include 40 healthy adults. They will receive moxibustion intervention.
Intervention Type
Diagnostic Test
Intervention Name(s)
Infrared thermal imaging
Intervention Description
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
Procedure
Intervention Name(s)
Moxibustion
Intervention Description
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.
Primary Outcome Measure Information:
Title
Temperature change of relevant acupoints or sites
Description
Infrared thermal imaging examination is used to assess temperature change of relevant acupoints or sites of the Heart and Lung meridians
Time Frame
Baseline, 15 minutes during moxibustion, 5 minutes after stopping moxibustion.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Inclusion criteria for CSAP patients 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 healthy adults 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: Exclusion criteria for CSAP patients 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. Exclusion criteria for healthy adults Participants have mental illness, severe depression, alcohol dependence or history of drug abuse; Pregnant or lactating participants ; Participants are participating in other trials.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yongliang Jiang
Phone
86-13858173136
Email
jyl2182@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianqiao Fang
Organizational Affiliation
Zhejiang Chinese Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
the Third affiliated hospital of Zhejiang Chinese Medical university
City
Hanzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hantong Hu
Phone
86-18667103032
Email
413351308@qq.com
First Name & Middle Initial & Last Name & Degree
Xiaoyu Li
Phone
86-15017541803
Email
752616172@qq.com

12. IPD Sharing Statement

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

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