- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03341663
The Diagnostic Value of Acupoint Sensitization Based on Stable Angina Pectoris
January 2, 2018 updated by: Sun Xin, West China Hospital
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 Overview
Status
Unknown
Study Type
Observational
Enrollment (Anticipated)
183
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sichuan
-
Chengdu, Sichuan, China, 610041
- Recruiting
- The West China Hospital of Sichuan University
-
Contact:
- Xin Sun
- Phone Number: 18980606047
- Email: sunx79@hotmail.com
-
Contact:
- Phone Number: 18980606047
- Email: sunx79@hotmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients were recruited from the department of cardiology in the West China Hospital of Sichuan University
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The degree of acupoint sensitization
Time Frame: About 1 hour
|
The value will be obtained through the electronic Von Frey instrument
|
About 1 hour
|
The degree of coronary artery stenosis
Time Frame: About 2 hours
|
Data will be obtained through coronary angiography
|
About 2 hours
|
Canadian Cardiovascular Society angina pectoris classification
Time Frame: About 1 hours
|
About 1 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 6, 2017
Primary Completion (Anticipated)
November 1, 2018
Study Completion (Anticipated)
November 1, 2018
Study Registration Dates
First Submitted
October 26, 2017
First Submitted That Met QC Criteria
November 13, 2017
First Posted (Actual)
November 14, 2017
Study Record Updates
Last Update Posted (Actual)
January 4, 2018
Last Update Submitted That Met QC Criteria
January 2, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201781590955
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stable Angina Pectoris
-
Zhejiang Chinese Medical UniversityThe Third Affiliated hospital of Zhejiang Chinese Medical University; The First...UnknownChronic Stable Angina PectorisChina
-
Zhejiang Chinese Medical UniversityThe Third Affiliated hospital of Zhejiang Chinese Medical University; The First...UnknownChronic Stable Angina PectorisChina
-
Zhejiang Chinese Medical UniversityThe First Affiliated Hospital of Zhejiang Chinese Medical UniversityUnknownChronic Stable Angina PectorisChina
-
Zhejiang Chinese Medical UniversityThe Third Affiliated hospital of Zhejiang Chinese Medical University; The First...Unknown
-
The People's Hospital of Liaoning ProvinceUnknownStable Angina Pectoris | Unstable Angina PectorisChina
-
Society for Advancement of Coronary Intervention...UnknownStable Angina Pectoris | Unstable Angina PectorisJapan
-
Region Örebro CountyBiosensors InternationalWithdrawnStable Angina Pectoris | Unstable Angina Pectoris | Myocardial Infacrtion
-
Neovasc Inc.Shockwave Medical, Inc.Active, not recruitingAngina Pectoris | Chronic Stable Angina | Angina Pectoris, StableNetherlands, Spain, United Kingdom, Germany, Italy, Switzerland, Belgium, France, Austria
-
Tasly Pharmaceuticals, Inc.RecruitingChronic Stable Angina PectorisUnited States
-
Atlantic Health SystemMallinckrodtTerminatedStable Angina Pectoris | Unstable Angina Pectoris | Silent IschemiaUnited States