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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

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.

Condition or disease Intervention/treatment
Stable Angina Pectoris Acupoint Sensitization Correlation Analysis Diagnostic Value 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

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Study Type : Observational
Estimated Enrollment : 183 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: The Diagnostic Value of Acupoint Sensitization Based on Stable Angina Pectoris
Actual Study Start Date : December 6, 2017
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina


Intervention Details:
  • 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


Primary Outcome Measures :
  1. The degree of acupoint sensitization [ Time Frame: About 1 hour ]
    The value will be obtained through the electronic Von Frey instrument

  2. The degree of coronary artery stenosis [ Time Frame: About 2 hours ]
    Data will be obtained through coronary angiography

  3. Canadian Cardiovascular Society angina pectoris classification [ Time Frame: About 1 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Older Adult)
Sexes 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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03341663


Locations
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China, Sichuan
The West China Hospital of Sichuan university Recruiting
Chengdu, Sichuan, China, 610041
Contact: Xin Sun    18980606047    sunx79@hotmail.com   
Contact    18980606047    sunx79@hotmail.com   
Sponsors and Collaborators
West China Hospital
  Study Documents (Full-Text)

Documents provided by Sun Xin, West China Hospital:
Study Protocol  [PDF] January 2, 2018


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Responsible Party: Sun Xin, Director, West China Hospital
ClinicalTrials.gov Identifier: NCT03341663     History of Changes
Other Study ID Numbers: 201781590955
First Posted: November 14, 2017    Key Record Dates
Last Update Posted: January 4, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sun Xin, West China Hospital:
Stable Angina Pectoris
Acupoint sensitization
Correlation analysis
Diagnostic value
Additional relevant MeSH terms:
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Angina Pectoris
Angina, Stable
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms