Stable Angina PectorisNCT03341663
The Diagnostic Value of Acupoint Sensitization Based on Stable Angina Pectoris
An observational study of Stable Angina Pectoris and Acupoint Sensitization, run by West China Hospital at 1 site in China.
Trial summary
Investigators adopt cross-sectional study design to carry out the exemplary research in the aspects of disease diagnosis.This study is designed to confirm the hypothesis "acupoint sensitization is associated with a severity of angina pectoris, which may contribute to the diagnosis of stable angina pectoris". Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Stable Angina Pectoris, Acupoint Sensitization, Correlation Analysis
- What is being tested?
- Coronary angiography,Canadian Cardiovascular Society angina pectoris classification for the severity of angina and electronic Von Frey instrument for testing the degree of acupoint sensitization
- How many people
- 183 participants
- Where
- 1 siteChina
- Study dates
- 6 Dec 2017to 29 Nov 2018
- Phase
- Observational
- 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 35 to 80 years
- All sexes
- Adult, Older adult
Study population: Patients were recruited from the department of cardiology in the West China Hospital of Sichuan University
Who may be able to join
- Patients meet the diagnostic criteria of ACC/AHA angina pectoris of coronary heart disease
- The frequency of angina attacks were greater or equal to twice a week over the previous 3 months
- Patients agree to do coronary angiography examination and sign the informed consent.
Who cannot join
- People with mental disabilities and intelligent obstacle
- Patients who can't accomplish the detection of acupoint sensitization
- Patients with allergic condition, especially the contrast media
- Patients with acute myocardial infarction, unstable angina, during arrhythmia and serious diseases which can affect the blood supply of myocardial
- Patients with skin or peripheral nerve paresthesia, pain or the detect area of skin ulcerate
- Pregnant or lactating women
- Patients who undergoing other clinical trials
Trial locations and contacts
1 site in 1 country.
China1 site
The West China Hospital of Sichuan university
Chengdu, Sichuan, 610041
About this study
Investigators adopt cross-sectional study design to carry out the exemplary research in the aspects of disease diagnosis.This study is designed to confirm the hypothesis "acupoint sensitization is associated with a severity of angina pectoris, which may contribute to the diagnosis of stable angina pectoris". After the eligible participants recruited in group, the coronary artery lesions will be evaluated through coronary angiography and the Canadian Cardiovascular Society(CCS) angina pectoris classification will also be evaluated at the same time. The degree of acupoint sensitization will be tested by the electronic Von Frey instrument by one professional acupuncturist with total 12 acupoints, including Shenmen,Yinxi, Shaohao,Jiquan,Neiguan, Ximen, Quze, Shanzhong, Juque, Jueyinyu, Xinyu, Duyu. Analysis were conducted to explore relationships between the degree of acupoint sensitization, the degree of coronary artery stenosis and CCS angina pectoris classification. Diagnostic value will be further analyzed in the final step.
- Being tested
- Coronary angiography,Canadian Cardiovascular Society angina pectoris classification for the severity of angina and electronic Von Frey instrument for testing the degree of acupoint sensitization
- Keywords
- Stable Angina Pectoris, Acupoint sensitization, Correlation analysis, Diagnostic value
- Medical subject headings
- Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary angiography,Canadian Cardiovascular Society angina pectoris classification for the severity of angina and electronic Von Frey instrument for testing the degree of acupoint sensitizationCombination product
All the interventions were tested for only once
What is being measured
The primary outcome is the main question the study is designed to answer.
The degree of acupoint sensitization
The value will be obtained through the electronic Von Frey instrument
Measured: About 1 hour
The degree of coronary artery stenosis
Data will be obtained through coronary angiography
Measured: About 2 hours
Canadian Cardiovascular Society angina pectoris classification
Measured: About 1 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2017
- Study start6 Dec 2017
- Primary completion28 Oct 2018
- Study completion29 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stable Angina PectorisStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sun Xin, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03341663
- Sponsor's protocol ID
- 201781590955
- Status last verified
- May 2024
- First submitted
- 26 Oct 2017
- Last updated
- 9 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnostic Value of Acupoint Sensitization Based on Stable Angina Pectoris
- ClinicalTrials.gov ID
- NCT03341663
- Acronym / sponsor ID
- 201781590955
- Keywords
- Stable Angina Pectoris, Acupoint sensitization, Correlation analysis, Diagnostic value
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 6 Dec 2017 (actual)
- Primary completion
- 28 Oct 2018 (actual)
- Study completion
- 29 Nov 2018 (actual)
- First posted
- 14 Nov 2017 (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.
Investigators adopt cross-sectional study design to carry out the exemplary research in the aspects of disease diagnosis.This study is designed to confirm the hypothesis "acupoint sensitization is associated with a severity of angina pectoris, which may contribute to the diagnosis of stable angina pectoris". After the eligible participants recruited in group, the coronary artery lesions will be evaluated through coronary angiography and the Canadian Cardiovascular Society(CCS) angina pectoris classification will also be evaluated at the same time. The degree of acupoint sensitization will be tested by the electronic Von Frey instrument by one professional acupuncturist with total 12 acupoints, including Shenmen,Yinxi, Shaohao,Jiquan,Neiguan, Ximen, Quze, Shanzhong, Juque, Jueyinyu, Xinyu, Duyu. Analysis were conducted to explore relationships between the degree of acupoint sensitization, the degree of coronary artery stenosis and CCS angina pectoris classification. Diagnostic value will be further analyzed in the final step.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients were recruited from the department of cardiology in the West China Hospital of Sichuan University
Key inclusion criteria (3 listed)
- Patients meet the diagnostic criteria of ACC/AHA angina pectoris of coronary heart disease
- The frequency of angina attacks were greater or equal to twice a week over the previous 3 months
- Patients agree to do coronary angiography examination and sign the informed consent.
Key exclusion criteria (7 listed)
- People with mental disabilities and intelligent obstacle
- Patients who can't accomplish the detection of acupoint sensitization
- Patients with allergic condition, especially the contrast media
- Patients with acute myocardial infarction, unstable angina, during arrhythmia and serious diseases which can affect the blood supply of myocardial
- Patients with skin or peripheral nerve paresthesia, pain or the detect area of skin ulcerate
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 |
|---|---|---|
| Coronary angiography,Canadian Cardiovascular Society angina pectoris classification for the severity of angina and electronic Von Frey instrument for testing the degree of acupoint sensitizationAll the interventions were tested for only once | Combination product | – |
Primary outcome
The degree of acupoint sensitization
Time frame: About 1 hour
The value will be obtained through the electronic Von Frey instrument
The degree of coronary artery stenosis
Time frame: About 2 hours
Data will be obtained through coronary angiography
Canadian Cardiovascular Society angina pectoris classification
Time frame: About 1 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stable Angina Pectoris and Acupoint Sensitization, run by West China Hospital 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 9 May 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The degree of acupoint sensitization (time frame: About 1 hour). The study lists 3 primary outcomes in all. 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 9 May 2024; AzTrials last refreshed its copy on 30 Oct 2026.