Overview

This trial is active, not recruiting.

Condition coronary artery disease
Sponsor West German Heart Center Essen
Start date May 2009
End date December 2013
Trial size 200 participants
Trial identifier NCT00917800, Essen 09-3981

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
patients referred to angiography because of suspected coronary artery disease

Primary Outcomes

Measure
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.
time frame: 1 week

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Diagnostic Benefits of HyperQ™ vs. Conventional ECG During Stress Test. A Comparison Study in Patients Referred for Angiography
Principal investigator Raimund Erbel, MD
Trial information was received from ClinicalTrials.gov and was last updated in June 2013.
Information provided to ClinicalTrials.gov by West German Heart Center Essen.