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

NCT00917800 | Unknown

• 1 other identifier: Essen 09-3981
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

angiography; exercise testing; high frequency ECG; coronary artery disease

Outcome Measures

Primary Outcomes (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.

  1 week

Study Arms (1)

suspected coronary artery disease

patients referred to angiography because of suspected coronary artery disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• West German Heart Center Essen: lead

Study Sites (1)

West German Heart Center

Essen, Germany

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Raimund Erbel, MD

  Director, West German Heart Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 8, 2009
• First Posted: June 10, 2009
• Study Start: May 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: June 12, 2013

Record last verified: 2013-06

Locations

DE (1)