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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03341663
Other study ID # 201781590955
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 6, 2017
Est. completion date November 29, 2018

Study information

Verified date May 2024
Source West China Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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". 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.


Recruitment information / eligibility

Status Completed
Enrollment 183
Est. completion date November 29, 2018
Est. primary completion date October 28, 2018
Accepts healthy volunteers
Gender All
Age group 35 Years to 80 Years
Eligibility 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 Design


Intervention

Combination Product:
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
All the interventions were tested for only once

Locations

Country Name City State
China The West China Hospital of Sichuan university Chengdu Sichuan

Sponsors (1)

Lead Sponsor Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The degree of acupoint sensitization The value will be obtained through the electronic Von Frey instrument About 1 hour
Primary The degree of coronary artery stenosis Data will be obtained through coronary angiography About 2 hours
Primary Canadian Cardiovascular Society angina pectoris classification About 1 hours
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