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

• Conditions: Acute Coronary Syndrome; Myocardial Ischemia
• Interventions: Other: Extra-corporeal ECG signal analysis

• Registration Number: NCT02579512
• Lead Sponsor: Taichung Veterans General Hospital

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.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-07-13
• Status Verified: 2015-09
• Study First Submitted QC: 2015-10-15
• Last Update Submitted: 2015-10-15
• Study First Posted: 2015-10-19
• Last Update Posted: 2015-10-19
• Primary Completion: 2016-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• patient with acute coronary syndrome who accepted percutaneous coronary intervention

Exclusion Criteria

• no percutaneous coronary intervention

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Extra-corporeal ECG Signal Analysis	Extra-corporeal ECG signal analysis	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan