The Diagnostic Benefits of the HyperQTM System in ECG Stress Testing

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.

Study Overview

• Status: Unknown
• Conditions: Myocardial Ischemia
• Intervention / Treatment: Device: Excercise stress test with high frequency ECG recording (HyperQ™ System)

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: Interventional
• Enrollment (Anticipated): 1200
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Haim Silber, MD; Phone Number: 09 7408811; Email: silber_h@mac.org.il
• Study Contact Backup: Name: Nechi Almogy, MD; Phone Number: 03 6474840; Email: nechi@bsp.co.il

Study Locations

• Israel
  • Kfar Saba, Israel
    • Recruiting
    • Dr. Silber Clinic
    • Contact: Haim Silber, MD; Phone Number: 09 7408811; Email: silber_h@mac.org.il
    • Principal Investigator: Haim Silber, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
ST changes
HyperQ results

Collaborators and Investigators

• Sponsor: Assuta Hospital Systems
• Collaborators: BSP Biological Signal Processing Ltd.
• Investigators: Principal Investigator: Haim Silber, MD, Maccabi Healthcare Services, Israel

Study record dates

Study Major Dates

• Study Start: August 1, 2006
• Primary Completion: December 7, 2022
• Study Completion: October 1, 2007

Study Registration Dates

• First Submitted: March 19, 2007
• First Submitted That Met QC Criteria: March 19, 2007
• First Posted (Estimate): March 20, 2007

Study Record Updates

• Last Update Posted (Estimate): April 17, 2015
• Last Update Submitted That Met QC Criteria: April 16, 2015
• Last Verified: October 1, 2006

More Information

Terms related to this study

• Keywords: Ischemia; Myocardial; HF-ECG
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Ischemia; Ischemia
• Other Study ID Numbers: MAC_01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No