Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00449579
Status:
UNKNOWN
Last Update Posted:
2015-04-17
First Post:
2007-03-19
Brief Title:
The Diagnostic Benefits of the HyperQTM System in ECG Stress Testing
Sponsor:
Assuta Hospital Systems
Organization:
Assuta Hospital Systems
Study Overview
Official Title:
The Diagnostic Benefits of the HyperQTM System in ECG Stress Testing
Status:
UNKNOWN
Status Verified Date:
2006-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 BSPs 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
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 BSPs 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 BSPs 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 tests results in the conventional manner eg 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 physicians 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
Following the test the physician will interpret the tests results in the conventional manner eg 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 physicians 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None