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

October 15, 2015 updated by: Taichung Veterans General Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Taichung, Taiwan, 40705
        • Recruiting
        • Taichung Veterans General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

myocardial Ischemia

Description

Inclusion Criteria:

  • patient with acute coronary syndrome who accepted percutaneous coronary intervention

Exclusion Criteria:

  • no percutaneous coronary intervention

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Extra-corporeal ECG Signal Analysis
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Adverse Cardiac Events (MACE)
Time Frame: within the first 180 days after PCI (percutaneous coronary intervention)
MACE including de novo lesion , intra-stent stenosis, cardiac death and re-myocardial infarction
within the first 180 days after PCI (percutaneous coronary intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taichung Veterans General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Anticipated)

May 1, 2016

Study Registration Dates

First Submitted

July 13, 2015

First Submitted That Met QC Criteria

October 15, 2015

First Posted (Estimate)

October 19, 2015

Study Record Updates

Last Update Posted (Estimate)

October 19, 2015

Last Update Submitted That Met QC Criteria

October 15, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IGA1041203

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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