Non Invasive Extra-corporeal ECG Signal Analysis Algorithm( NID Algorithm) for Myocardial Ischemia
1 other identifier
observational
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 13, 2015
CompletedFirst Posted
Study publicly available on registry
October 19, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedOctober 19, 2015
September 1, 2015
11 months
July 13, 2015
October 15, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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)
Study Arms (1)
Extra-corporeal ECG Signal Analysis
Interventions
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.
Eligibility Criteria
myocardial Ischemia
You may qualify if:
- patient with acute coronary syndrome who accepted percutaneous coronary intervention
You may not qualify if:
- no percutaneous coronary intervention
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
Related Publications (3)
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.
PMID: 17462756RESULTSharir 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.
PMID: 22169126RESULTChoi 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.
PMID: 24255651RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2015
First Posted
October 19, 2015
Study Start
June 1, 2015
Primary Completion
May 1, 2016
Last Updated
October 19, 2015
Record last verified: 2015-09