NCT02579512

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

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 13, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 19, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Last Updated

October 19, 2015

Status Verified

September 1, 2015

Enrollment Period

11 months

First QC Date

July 13, 2015

Last Update Submit

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

Other: 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.

Extra-corporeal ECG Signal Analysis

Eligibility Criteria

Age20 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

RECRUITING

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.

  • 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.

  • 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.

MeSH Terms

Conditions

Acute Coronary SyndromeMyocardial Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Central Study Contacts

Yu-Tsung Cheng, M.D.

CONTACT

Hsian-Min Chen, PhD

CONTACT

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

Locations