Comparison of the HyperQ Versus Conventional Electrocardiogram (ECG) to Detect Ischemia
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2013 by West German Heart Center Essen.
Recruitment status was Active, not recruiting
Information provided by (Responsible Party):
N. Reinsch, West German Heart Center Essen
First received: June 8, 2009
Last updated: June 11, 2013
Last verified: June 2013
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.
||Observational Model: Case-Only
Time Perspective: Prospective
||Diagnostic Benefits of HyperQ™ vs. Conventional ECG During Stress Test. A Comparison Study in Patients Referred for Angiography
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2013 (Final data collection date for primary outcome measure)
suspected coronary artery disease
patients referred to angiography because of suspected coronary artery disease
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients referred to the West German Heart Center in Essen for coronary angiography
- 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.
- 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.
- Having taken beta blockers within 24 hours before the exercise test.
- Pregnancy or suspected pregnancy.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00917800
|West German Heart Center
|Essen, Germany |
West German Heart Center Essen
||Raimund Erbel, MD
||Director, West German Heart Center
No publications provided
||N. Reinsch, Principal Investigator, West German Heart Center Essen
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 8, 2009
||June 11, 2013
||Germany: Federal Institute for Drugs and Medical Devices
Keywords provided by West German Heart Center Essen:
high frequency ECG
coronary artery disease
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 30, 2015
Coronary Artery Disease
Arterial Occlusive Diseases