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CompletedNCT03341663Updated May 9, 2024

The Diagnostic Value of Acupoint Sensitization Based on Stable Angina Pectoris

An observational study in Stable Angina Pectoris, Acupoint Sensitization and Correlation Analysis, sponsored by West China Hospital. Completed at 1 site in China. Open to participants aged 35 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-05-09.

Sponsored by West China Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
183
Ages
35 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • Stable Angina Pectoris
  • Acupoint sensitization
  • Correlation analysis
  • Diagnostic value
03

Who can participate

Ages eligible
35 Years to 80 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients were recruited from the department of cardiology in the West China Hospital of Sichuan University

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

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
04

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
183 participants (actual)
Patient registry
No

Interventions

  • Combination productCoronary 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

05

What researchers measure

Primary outcomes

  1. The degree of acupoint sensitization

    The value will be obtained through the electronic Von Frey instrument

    Time frame: About 1 hour

  2. The degree of coronary artery stenosis

    Data will be obtained through coronary angiography

    Time frame: About 2 hours

  3. Canadian Cardiovascular Society angina pectoris classification

    Time frame: About 1 hours

06

Study locations

1 site
  • The West China Hospital of Sichuan university
    Chengdu, Sichuan 610041, China
07

References and documents

Study documents

  • Study protocol · Jan 2, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03341663
Lead sponsor
West China Hospital
Responsible party
Sun Xin (Director, West China Hospital) — Principal investigator
First posted
Nov 14, 2017
Start date
Dec 6, 2017
Primary completion
Oct 28, 2018
Completion
Nov 29, 2018
Last update
May 9, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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