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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
N. Reinsch, West German Heart Center Essen
ClinicalTrials.gov Identifier:
NCT00917800
First received: June 8, 2009
Last updated: June 11, 2013
Last verified: June 2013
  Purpose

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
Coronary Artery Disease

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by West German Heart Center Essen:

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: 200
Study Start Date: May 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
suspected coronary artery disease
patients referred to angiography because of suspected coronary artery disease

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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

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

No publications provided

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
Study First Received: June 8, 2009
Last Updated: June 11, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

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

ClinicalTrials.gov processed this record on November 25, 2014