Comparison of the HyperQ Versus Conventional Electrocardiogram (ECG) to Detect Ischemia

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

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-05-31

Study Completion Date

2013-12-31

Brief Summary

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The purpose of the investigation is to verify the efficiency of the HyperQ™ system in detecting exercise induced ischemia, with higher specificity and sensitivity than conventional ECG Stress testing. The study will be carried out by applying the HyperQ™ system during cycle ergometer stress testing in patients who are referred for angiography at the Department of Cardiology, Essen University Hospital, Essen, Germany. The HyperQ™ results will then be compared to the standard ECG stress test results using the angiography results as the gold standard. The study will be considered successful if analysis of the HyperQ provides a statistically significant improvement over the diagnostic accuracy of conventional ECG stress testing analysis.

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Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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suspected coronary artery disease

patients referred to angiography because of suspected coronary artery disease

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* A patient who was referred to angiography.
* A patient who is able (i.e., no contraindications) to perform an exercise stress test
* A patient who signed an informed consent form.

Exclusion Criteria

* Contraindications for an exercise test.
* Wolff-Parkinson-White (pre-excitation) syndrome.
* Left Bundle branch block, Complete Right bundle branch block or QRS duration \> 120 ms, change in QRS morphology during exercise.
* Atrial Fibrillation or significant ventricular arrhythmia
* Treatment with Digoxin.
* Pacemaker.
* Having taken beta blockers within 24 hours before the exercise test.
* Pregnancy or suspected pregnancy.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No