The Diagnostic Benefits of the HyperQTM System in ECG Stress Testing

Tracking Information
First Submitted Date ICMJE	March 19, 2007
First Posted Date ICMJE	March 20, 2007
Last Update Posted Date	April 17, 2015
Study Start Date ICMJE	August 2006
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE; (submitted: March 19, 2007)	ST changes; HyperQ results
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00449579 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	The Diagnostic Benefits of the HyperQTM System in ECG Stress Testing
Official Title ICMJE	The Diagnostic Benefits of the HyperQTM System in ECG Stress Testing
Brief Summary	The main objective of this study is to determine the usefulness of the HyperQ™ System in improving the positive predictive value of conventional ECG stress testing. Patients who are referred for stress test will perform an ECG stress test on a treadmill, with high-frequency ECG recording from conventional 12 leads using BSP's HyperQ™ System. Conventional 12 lead ECG, as well as HyperQ™ recordings will be provided by the HyperQ™ System. The results of the conventional test and the HyperQ™ data will be compared, using one of three cardiac tests (stress echocardiography, SPECT myocardial perfusion imaging and angiography) as gold standards. Statistical analysis will compare the sensitivity, specificity, PPV and NPV of the conventional and HyperQ™ stress ECG in detecting myocardial ischemia.
Detailed Description	The study population will comprise of 1200 patients referred to stress test in three Maccabi clinics or cardiac medical centers. All patients will perform an ECG stress test with high-frequency ECG recording from conventional 12 leads using BSP's HyperQ™ System. The recording will be done without affecting or interfering with any aspect of the normal due course of the test. Standard Bruce protocol or modified Bruce protocol will be used, with standard test termination indications. Two minutes of rest ECG will be recorded prior to stating the protocol. Following the test, the physician will interpret the test's results in the conventional manner (e.g. ST changes, chest pain, etc) and decide whether the subject should be referred to additional tests. HyperQ™ data will be analyzed in two phases: (i) Interpretation by the physician in a non-blinded manner one day following the stress test and (ii) after performing all the exercise tests of the study group, blindly to the conventional diagnosis and the HyperQ™ analysis done previously, as well as to other outcomes of imaging procedures. The first HyperQ™ reading will be used to detect the subjects who were positive according to the HyperQ™ system but negative according to the conventional stress testing. These subjects will be referred by the physician to further clinical investigation. The first reading will also be used to assess the physician's interpretation in a scenario that represents a realistic clinical setting, while the second reading will be used to examine the unbiased clinical benefit of HyperQ™ data.
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Screening
Condition ICMJE	Myocardial Ischemia
Intervention ICMJE	Device: Excercise stress test with high frequency ECG recording (HyperQ™ System)
Study Arms	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Unknown status
Estimated Enrollment ICMJE; (submitted: March 19, 2007)	1200
Original Enrollment ICMJE	Same as current
Study Completion Date	October 2007
Primary Completion Date	Not Provided
Eligibility Criteria ICMJE	Inclusion Criteria: Subject referred to stress ECG; Subjects age ≥ 45; Subject signed an Informed Consent form Exclusion Criteria: Subject with contraindications for stress ECG; Subject with implantable pacemaker or defibrillator; Subject with LBBB; Subject with QRS duration ≥ 110 mSec; Subject with Wolff-Parkinson-White Syndrome
Sex/Gender	Sexes Eligible for Study: All
Ages	45 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Israel
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00449579
Other Study ID Numbers ICMJE	MAC_01
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor ICMJE	Assuta Hospital Systems
Collaborators ICMJE	BSP Biological Signal Processing Ltd.
Investigators ICMJE	Principal Investigator: Haim Silber, MD Maccabi Healthcare Services, Israel
PRS Account	Assuta Hospital Systems
Verification Date	October 2006
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP