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The Diagnostic Value of Acupoint Sensitization Based on Stable Angina Pectoris

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ClinicalTrials.gov Identifier: NCT03341663
Recruitment Status : Recruiting
First Posted : November 14, 2017
Last Update Posted : January 4, 2018
Sponsor:
Information provided by (Responsible Party):
Sun Xin, West China Hospital

Tracking Information
First Submitted Date October 26, 2017
First Posted Date November 14, 2017
Last Update Posted Date January 4, 2018
Actual Study Start Date December 6, 2017
Estimated Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 13, 2017)
  • 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 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03341663 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Diagnostic Value of Acupoint Sensitization Based on Stable Angina Pectoris
Official Title The Diagnostic Value of Acupoint Sensitization Based on Stable Angina Pectoris
Brief 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients were recruited from the department of cardiology in the West China Hospital of Sichuan University
Condition
  • Stable Angina Pectoris
  • Acupoint Sensitization
  • Correlation Analysis
  • Diagnostic Value
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
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 13, 2017)
183
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 2018
Estimated Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 35 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03341663
Other Study ID Numbers 201781590955
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Sun Xin, West China Hospital
Study Sponsor West China Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account West China Hospital
Verification Date January 2018