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 2009 by West German Heart Center Essen.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
West German Heart Center Essen
ClinicalTrials.gov Identifier:
NCT00917800
First received: June 8, 2009
Last updated: February 19, 2010
Last verified: June 2009

June 8, 2009
February 19, 2010
May 2009
December 2010   (final data collection date for primary outcome 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 ] [ Designated as safety issue: No ]
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: end of data collection ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00917800 on ClinicalTrials.gov Archive Site
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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

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.

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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Probability Sample

Patients referred to the West German Heart Center in Essen for coronary angiography

Coronary Artery Disease
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suspected coronary artery disease
patients referred to angiography because of suspected coronary artery disease
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
December 2010
December 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Nico Reinsch, MD 49 (0) 201/723-84890 Nico.Reinsch@uk-essen.de
Germany
 
NCT00917800
Essen 09-3981
No
Professor R. Erbel, Universitatsklinikum Essen, Westdeutsches Herzzentrum Essen
West German Heart Center Essen
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Principal Investigator: Raimund Erbel, MD Director, West German Heart Center
West German Heart Center Essen
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP