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Clinical Trials/NCT02579512
NCT02579512
Unknown
Not Applicable

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

Taichung Veterans General Hospital1 site in 1 country500 target enrollmentJune 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Coronary Syndrome
Sponsor
Taichung Veterans General Hospital
Enrollment
500
Locations
1
Primary Endpoint
Major Adverse Cardiac Events (MACE)
Last Updated
10 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
June 2015
End Date
May 2016
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • patient with acute coronary syndrome who accepted percutaneous coronary intervention

Exclusion Criteria

  • no percutaneous coronary intervention

Outcomes

Primary Outcomes

Major Adverse Cardiac Events (MACE)

Time Frame: within the first 180 days after PCI (percutaneous coronary intervention)

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

Study Sites (1)

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