Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00310622
Status:
UNKNOWN
Last Update Posted:
2007-03-01
First Post:
2006-04-02
Brief Title:
Assessment of HyperQ Signal for Detecting Ischemia During Dobutamine Stress ECG
Sponsor:
BSP Biological Signal Processing Ltd
Organization:
BSP Biological Signal Processing Ltd
Study Overview
Official Title:
An Assessment of the HyperQ Signal for Detecting Ischemia During Dobutamine Stress Echocardiography DSE
Status:
UNKNOWN
Status Verified Date:
2007-02
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 purpose of the study is to verify the ability of the HyperQ signal to detect Dobutamine induced Ischemia The gold standard for ischemia will be the results of Angiography if performed or Echocardiographic imaging which was performed during the test
Detailed Description:
Subjects referred for Dobutamine Stress Echocardiography who will sign an Informed consent form will go through the test High resolution ECG from 12 leads will be recorded using BSPs HyperQ system before during and following the Echo testing This wil be done without interfering or affecting any aspect of the normal procedure Standard Protocol will be used with standard test termination indications
The Diagnostic stage will include analysis of the hyperQ signal aiming to classify results as ischemic or non-ischemic
The HyperQ data will be compared to DSE results which will be used as the gold standard for this study unless Angiography results are obtained
An additional comparison evaluation will be performed to assess the advantage of the HyperQ results on the ST-changes results obtained from conventional ECGIn addition all recruited subjects will be followed for up to 12 monthsDuring this period a phone call will be performed every 3 months to evaluate cardiac status hospitalization and especially Angiography procedures
The Diagnostic stage will include analysis of the hyperQ signal aiming to classify results as ischemic or non-ischemic
The HyperQ data will be compared to DSE results which will be used as the gold standard for this study unless Angiography results are obtained
An additional comparison evaluation will be performed to assess the advantage of the HyperQ results on the ST-changes results obtained from conventional ECGIn addition all recruited subjects will be followed for up to 12 monthsDuring this period a phone call will be performed every 3 months to evaluate cardiac status hospitalization and especially Angiography procedures
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