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

Acute Coronary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02579512
• Other study ID #: IGA1041203
• Status: Recruiting
• Phase: N/A
• First received: July 13, 2015
• Last updated: October 15, 2015
• Start date: June 2015

Study information

• Verified date: September 2015
• Source: Taichung Veterans General Hospital
• Contact: Yu-Tsung Cheng, M.D.
• Phone: 886423592525
• Email: asphyxia747[@]hotmail.com
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 95 Years

Eligibility

Inclusion Criteria:

• patient with acute coronary syndrome who accepted percutaneous coronary intervention

Exclusion Criteria:

• no percutaneous coronary intervention

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Coronary Artery Disease
• Ischemia
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Taichung Veterans General Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Taichung Veterans General Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (3)

Choi JO, Chang SA, Park SJ, Lee SC, Park SW. Improved detection of ischemic heart disease by combining high-frequency electrocardiogram analysis with exercise stress echocardiography. Korean Circ J. 2013 Oct;43(10):674-80. doi: 10.4070/kcj.2013.43.10.674. — View Citation

Lipton JA, Warren SG, Broce M, Abboud S, Beker A, Sörnmo L, Lilly DR, Maynard C, Lucas BD Jr, Wagner GS. High-frequency QRS electrocardiogram analysis during exercise stress testing for detecting ischemia. Int J Cardiol. 2008 Feb 29;124(2):198-203. Epub 2 — View Citation

Sharir T, Merzon K, Kruchin I, Bojko A, Toledo E, Asman A, Chouraqui P. Use of electrocardiographic depolarization abnormalities for detection of stress-induced ischemia as defined by myocardial perfusion imaging. Am J Cardiol. 2012 Mar 1;109(5):642-50. d — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Adverse Cardiac Events (MACE)	MACE including de novo lesion , intra-stent stenosis, cardiac death and re-myocardial infarction	within the first 180 days after PCI (percutaneous coronary intervention)	No