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

NCT ID: NCT02579512

Last Updated: 2015-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Brief Summary

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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

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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.

Conditions

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Acute Coronary Syndrome Myocardial Ischemia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Extra-corporeal ECG Signal Analysis

Extra-corporeal ECG signal analysis

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* patient with acute coronary syndrome who accepted percutaneous coronary intervention

Exclusion Criteria

* no percutaneous coronary intervention
Minimum Eligible Age

20 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taichung Veterans General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Taichung Veterans General Hospital

Taichung, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Yu-Tsung Cheng, M.D.

Role: CONTACT

886423592525 ext. 3141

Hsian-Min Chen, PhD

Role: CONTACT

886423592525 ext. 4427

Facility Contacts

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Yu-Tsung Cheng, M.D.

Role: primary

886423592525 ext. 3141

References

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Lipton JA, Warren SG, Broce M, Abboud S, Beker A, Sornmo 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. doi: 10.1016/j.ijcard.2007.02.002. Epub 2007 Apr 25.

Reference Type RESULT
PMID: 17462756 (View on PubMed)

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. doi: 10.1016/j.amjcard.2011.10.022. Epub 2011 Dec 9.

Reference Type RESULT
PMID: 22169126 (View on PubMed)

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. Epub 2013 Oct 30.

Reference Type RESULT
PMID: 24255651 (View on PubMed)

Other Identifiers

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IGA1041203

Identifier Type: -

Identifier Source: org_study_id

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