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

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ClinicalTrials.gov Identifier: NCT00917800
Recruitment Status : Unknown
Verified June 2013 by N. Reinsch, West German Heart Center Essen.
Recruitment status was:  Active, not recruiting
First Posted : June 10, 2009
Last Update Posted : June 12, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Coronary Artery Disease

Study Design

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Diagnostic Benefits of HyperQ™ vs. Conventional ECG During Stress Test. A Comparison Study in Patients Referred for Angiography
Study Start Date : May 2009
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
suspected coronary artery disease
patients referred to angiography because of suspected coronary artery disease


Outcome Measures

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients referred to the West German Heart Center in Essen for coronary angiography
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00917800


Locations
Germany
West German Heart Center
Essen, Germany
Sponsors and Collaborators
West German Heart Center Essen
Investigators
Principal Investigator: Raimund Erbel, MD Director, West German Heart Center
More Information

Responsible Party: N. Reinsch, Principal Investigator, West German Heart Center Essen
ClinicalTrials.gov Identifier: NCT00917800     History of Changes
Other Study ID Numbers: Essen 09-3981
First Posted: June 10, 2009    Key Record Dates
Last Update Posted: June 12, 2013
Last Verified: June 2013

Keywords provided by N. Reinsch, West German Heart Center Essen:
angiography
exercise testing
high frequency ECG
coronary artery disease

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases