Chronic Stable Angina PectorisNCT04264559
The Heat Transport Characteristics of the Heart and Lung Meridians: A Study of CSAP Patients and Healthy Adults
A study testing Infrared thermal imaging and Moxibustion in people with Chronic Stable Angina Pectoris, run by Zhejiang Chinese Medical University at 1 site in China.
Trial 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… 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?
- Infrared thermal imaging and Moxibustion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Mar 2020to 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 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.
Who cannot join
- 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;
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- 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.
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
About this study
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
Read the 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.
- Conditions
- Chronic Stable Angina Pectoris
- Being tested
- Infrared thermal imaging, Moxibustion
- Keywords
- stable angina pectoris, meridian, infrared thermal imaging
- Medical subject headings
- Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
MoxibustionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy control group | Other | This group will include 40 healthy adults. Receives: Diagnostic Test: Infrared thermal imaging |
| CSAP group | Other | This study will include 40 patients with chronic stable angina pectoris (CSAP). Receives: Diagnostic Test: Infrared thermal imaging |
| Healthy intervention group | Experimental | This group will include 40 healthy adults. They will receive moxibustion intervention. Receives: Diagnostic Test: Infrared thermal imaging; Procedure: Moxibustion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 15 minutes during moxibustion, 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.
- First posted11 Feb 2020
- Study startMar 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Chinese Medical University
- Sponsor type
- Other government
- Collaborators
- The First Affiliated Hospital of Zhejiang Chinese Medical University
- Responsible party
- Principal investigator, Jianqiao Fang, Zhejiang Chinese Medical University
- Investigators
- Jianqiao Fang, Principal investigator, Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04264559
- Sponsor's protocol ID
- 2019ZY009-MERIDIAN
- Status last verified
- Feb 2020
- First submitted
- 8 Feb 2020
- Last updated
- 11 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Heat Transport Characteristics of the Heart and Lung Meridians: A Study of CSAP Patients and Healthy Adults
- ClinicalTrials.gov ID
- NCT04264559
- Acronym / sponsor ID
- 2019ZY009-MERIDIAN
- Conditions
- Chronic Stable Angina Pectoris
- Keywords
- stable angina pectoris, meridian, infrared thermal imaging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Zhejiang Chinese Medical UniversityOther government
- Collaborators
- The First Affiliated Hospital of Zhejiang Chinese Medical University
- Study start
- Mar 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 11 Feb 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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy control group | Other | Diagnostic Test: Infrared thermal imagingThis group will include 40 healthy adults. |
| CSAP group | Other | Diagnostic Test: Infrared thermal imagingThis study will include 40 patients with chronic stable angina pectoris (CSAP). |
| Healthy intervention group | Experimental | Diagnostic Test: Infrared thermal imaging, Procedure: MoxibustionThis group will include 40 healthy adults. They will receive moxibustion intervention. |
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 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;
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 |
|---|---|---|
| Infrared thermal imagingA 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. | Diagnostic test | CSAP group, Healthy control group, Healthy intervention group |
| MoxibustionTwo 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. | Procedure or surgery | Healthy intervention group |
Primary outcome
Temperature change of relevant acupoints or sites
Time frame: Baseline, 15 minutes during moxibustion, 5 minutes after stopping moxibustion.
Infrared thermal imaging examination is used to assess temperature change of relevant acupoints or sites of 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 11 Feb 2020.
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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.
Jianqiao Fang 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 Infrared thermal imaging and Moxibustion 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 11 Feb 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 (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?
Temperature change of relevant acupoints or sites (time frame: Baseline, 15 minutes during moxibustion, 5 minutes after stopping moxibustion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Feb 2020.