The Diagnostic Benefits of the HyperQTM System in ECG Stress Testing

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2006 by Assuta Hospital Systems.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
BSP Biological Signal Processing Ltd.
Information provided by:
Assuta Hospital Systems
ClinicalTrials.gov Identifier:
NCT00449579
First received: March 19, 2007
Last updated: February 7, 2013
Last verified: October 2006
  Purpose

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.


Condition Intervention Phase
Myocardial Ischemia
Device: Excercise stress test with high frequency ECG recording (HyperQ™ System)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: The Diagnostic Benefits of the HyperQTM System in ECG Stress Testing

Resource links provided by NLM:


Further study details as provided by Assuta Hospital Systems:

Primary Outcome Measures:
  • ST changes
  • HyperQ results

Estimated Enrollment: 1200
Study Start Date: August 2006
Estimated Study Completion Date: October 2007
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.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT00449579

Contacts
Contact: Haim Silber, MD 09 7408811 silber_h@mac.org.il
Contact: Nechi Almogy, MD 03 6474840 nechi@bsp.co.il

Locations
Israel
Dr. Silber Clinic Recruiting
Kfar Saba, Israel
Contact: Haim Silber, MD    09 7408811    silber_h@mac.org.il   
Principal Investigator: Haim Silber, MD         
Sponsors and Collaborators
Assuta Hospital Systems
BSP Biological Signal Processing Ltd.
Investigators
Principal Investigator: Haim Silber, MD Maccabi Healthcare Services, Israel
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00449579     History of Changes
Other Study ID Numbers: MAC_01
Study First Received: March 19, 2007
Last Updated: February 7, 2013
Health Authority: Israel: Ethics Commission

Keywords provided by Assuta Hospital Systems:
Ischemia
Myocardial
HF-ECG

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

ClinicalTrials.gov processed this record on July 22, 2014