NCT04264559

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

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 Mar 2020

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 11, 2020

Completed
19 days until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

February 11, 2020

Status Verified

February 1, 2020

Enrollment Period

9 months

First QC Date

February 8, 2020

Last Update Submit

February 8, 2020

Conditions

Chronic Stable Angina Pectoris

Keywords

stable angina pectorismeridianinfrared thermal imaging

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline, 15 minutes during moxibustion, 5 minutes after stopping moxibustion.

Study Arms (3)

Healthy control group

OTHER

This group will include 40 healthy adults.

Diagnostic Test: Infrared thermal imaging

CSAP group

OTHER

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

Diagnostic Test: Infrared thermal imaging

Healthy intervention group

EXPERIMENTAL

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

Diagnostic Test: Infrared thermal imagingProcedure: Moxibustion

Interventions

Infrared thermal imagingDIAGNOSTIC_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 groupHealthy control groupHealthy intervention group
MoxibustionPROCEDURE

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.

Healthy 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 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.

You may not qualify if:

  • 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.

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

MeSH Terms

Conditions

Angina, Stable

Interventions

Moxibustion

Condition Hierarchy (Ancestors)

Angina PectorisMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acupuncture TherapyComplementary TherapiesTherapeutics

Study Officials

  • Jianqiao Fang

    Zhejiang Chinese Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yongliang Jiang

CONTACT

86-13858173136jyl2182@126.com

Study Design

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

Study Record Dates

First Submitted

February 8, 2020

First Posted

February 11, 2020

Study Start

March 1, 2020

Primary Completion

December 1, 2020

Study Completion

December 1, 2021

Last Updated

February 11, 2020

Record last verified: 2020-02

Locations

CN(1)