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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00917800

Enrollment

200

Registered

2009-06-10

Start date

2009-05-31

Completion date

2013-12-31

Last updated

2013-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

angiography, exercise testing, high frequency ECG, coronary artery disease

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Countries

Germany

Outcome results