Non Invasive Extra-corporeal ECG Signal Analysis Algorithm( NID Algorithm) for Myocardial Ischemia

Sponsor
Taichung Veterans General Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02579512
Collaborator
(none)
500
1

Study Details

Study Description

Brief Summary

The NIA algorithm is similar to the traditional 12-lead ECG equipment. By analyzing patient data, NIA algorithm provides more detailed results compared to traditional 12-lead ECG. Patients with suspected coronary artery disease are conventionally diagnosed and treated by cardiac catheterization. However, cardiac catheterization is invasive procedure. Unless clinical diagnosis is evident before cardiac catheterization, a treadmill exercise test, a nuclear medicine myocardial perfusion test, or a multi-direction coronary CT angiogram is usually performed to increase the accuracy of diagnosis. But these examinations are not accessible to all patients, and are time-consuming and costly.

Condition or Disease Intervention/Treatment Phase
  • Other: Extra-corporeal ECG signal analysis

Detailed Description

In this project, the investigators hope to compare the data collected under this new technology of NIA algorithm with results from final diagnoses of cardiac catheterization. As the NIA algorithm is a fast and less costly, if it provides more sensitivity and specificity than does exercise ECG, nuclear myocardial perfusion test, and high-resolution coronary CT angiogram, it will expedite diagnosis for patients with coronary artery disease.

Study Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
Non Invasive Extra-corporeal ECG Signal Analysis Algorithm( NID Algorithm) for Myocardial Ischemia
Study Start Date :
Jun 1, 2015
Anticipated Primary Completion Date :
May 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Extra-corporeal ECG Signal Analysis

Other: Extra-corporeal ECG signal analysis
The NIA algorithm is similar to the traditional 12-lead ECG equipment. By analyzing patient data, NIA algorithm provides more detailed results compared to traditional 12-lead ECG. Patients with suspected coronary artery disease are conventionally diagnosed and treated by cardiac catheterization. However, cardiac catheterization is invasive procedure. Unless clinical diagnosis is evident before cardiac catheterization, a treadmill exercise test, a nuclear medicine myocardial perfusion test, or a multi-direction coronary CT angiogram is usually performed to increase the accuracy of diagnosis. But these examinations are not accessible to all patients, and are time-consuming and costly.

Outcome Measures

Primary Outcome Measures

  1. Major Adverse Cardiac Events (MACE) [within the first 180 days after PCI (percutaneous coronary intervention)]

    MACE including de novo lesion , intra-stent stenosis, cardiac death and re-myocardial infarction

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 95 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • patient with acute coronary syndrome who accepted percutaneous coronary intervention
Exclusion Criteria:
  • no percutaneous coronary intervention

Contacts and Locations

Locations

Site City State Country Postal Code
1 Taichung Veterans General Hospital Taichung Taiwan 40705

Sponsors and Collaborators

  • Taichung Veterans General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Taichung Veterans General Hospital
ClinicalTrials.gov Identifier:
NCT02579512
Other Study ID Numbers:
  • IGA1041203
First Posted:
Oct 19, 2015
Last Update Posted:
Oct 19, 2015
Last Verified:
Sep 1, 2015

Study Results

No Results Posted as of Oct 19, 2015