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

• Conditions: Coronary Artery Disease

• Registration Number: NCT00917800
• Lead Sponsor: West German Heart Center Essen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-06-08
• Study First Submitted QC: 2009-06-08
• Study First Posted: 2009-06-10
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-11
• Last Update Posted: 2013-06-12
• Primary Completion: 2013-12
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective of this study is to determine the incremental diagnostic value of HyperQ data over exercise stress testing parameters to detect significant coronary artery disease (CAD) in patients referred for coronary angiography.	1 week

Trial Locations

Locations (1)

West German Heart Center; 🇩🇪 Essen, Germany