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

Coronary Artery Disease Clinical Trial

Official title:

Diagnostic Benefits of HyperQ™ vs. Conventional ECG During Stress Test. A Comparison Study in Patients Referred for Angiography

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00917800
• Other study ID #: Essen 09-3981
• Status: Active, not recruiting
• Phase: N/A
• First received: June 8, 2009
• Last updated: June 11, 2013
• Start date: May 2009
• Est. completion date: December 2013

Study information

• Verified date: June 2013
• Source: West German Heart Center Essen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
Germany	West German Heart Center	Essen

Sponsors (1)

Lead Sponsor	Collaborator
West German Heart Center Essen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No