NCT03341663

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
183

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2017

Completed
19 days until next milestone

First Posted

Study publicly available on registry

November 14, 2017

Completed
22 days until next milestone

Study Start

First participant enrolled

December 6, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2018

Completed
Last Updated

May 9, 2024

Status Verified

May 1, 2024

Enrollment Period

11 months

First QC Date

October 26, 2017

Last Update Submit

May 7, 2024

Conditions

Keywords

Stable Angina PectorisAcupoint sensitizationCorrelation analysisDiagnostic value

Outcome Measures

Primary Outcomes (3)

  • The degree of acupoint sensitization

    The value will be obtained through the electronic Von Frey instrument

    About 1 hour

  • The degree of coronary artery stenosis

    Data will be obtained through coronary angiography

    About 2 hours

  • Canadian Cardiovascular Society angina pectoris classification

    About 1 hours

Interventions

Eligibility Criteria

Age35 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The West China Hospital of Sichuan university

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Angina, Stable

Condition Hierarchy (Ancestors)

Angina PectorisMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

October 26, 2017

First Posted

November 14, 2017

Study Start

December 6, 2017

Primary Completion

October 28, 2018

Study Completion

November 29, 2018

Last Updated

May 9, 2024

Record last verified: 2024-05

Locations