The Diagnostic Value of Acupoint Sensitization Based on Stable Angina Pectoris

Stable Angina Pectoris Clinical Trial

Official title:

The Diagnostic Value of Acupoint Sensitization Based on Stable Angina Pectoris

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03341663
• Other study ID #: 201781590955
• Status: Recruiting
• Phase: N/A
• First received: October 26, 2017
• Last updated: January 2, 2018
• Start date: December 6, 2017
• Est. completion date: November 2018

Study information

• Verified date: January 2018
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• 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: Recruiting
• Enrollment: 183
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• 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

Related Conditions & MeSH terms

• Acupoint Sensitization
• Angina Pectoris
• Angina, Stable
• Correlation Analysis
• Diagnostic Value
• Stable Angina Pectoris

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