Ignite Creation Date:
2024-05-05 @ 11:38 PM
Last Modification Date:
2024-10-26 @ 10:36 AM
Study NCT ID:
NCT01374555
Status:
TERMINATED
Last Update Posted:
2018-04-18
First Post:
2011-06-14
Brief Title:
Evaluation of the CardioSond Electronic Stethoscope in the Detection of Coronary Artery Disease
Sponsor:
SonoMedica Inc
Organization:
SonoMedica Inc
Study Overview
Official Title:
Validation of the CardioSond Sonospectrographic Digital Electronic Stethoscope in Diagnosing Coronary Artery Disease Versus CT Angiography
Status:
TERMINATED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Inconsistent data taken from Phase I cohort
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study is designed to evaluate the predictive accuracy of the CardioSond digital electronic stethoscope in the detection of coronary artery disease CAD in patients with and without known disease who are referred to cardiac computed tomography angiography CT scans
Detailed Description:
The CardioSond is a noninvasive medical device which detects heart sounds using ultrasensitive acoustic technology The CardioSond produces a flow micro bruit score which is used to determine the likelihood of coronary artery disease
The CardioSond exam will be given to patients two times once prior to administration of vasodilators and potential beta blockade agents as part of the normal cardiac CT angiography protocol and again immediately post CT angiography No other data will be taken on the patient and the patients involvement in the study will cease after data collection
CT angiography data will be analyzed at a core lab at Medstar Research Institute and withheld from SonoMedica until all CardioSond acoustic data is analyzed and flow micro bruit scores are determined
A data review panel lead by the principal investigator will examine the results of both the CardioSond and CT angiography data to determine the comparative accuracy of the CardioSond in detecting CAD in the study population
The CardioSond exam will be given to patients two times once prior to administration of vasodilators and potential beta blockade agents as part of the normal cardiac CT angiography protocol and again immediately post CT angiography No other data will be taken on the patient and the patients involvement in the study will cease after data collection
CT angiography data will be analyzed at a core lab at Medstar Research Institute and withheld from SonoMedica until all CardioSond acoustic data is analyzed and flow micro bruit scores are determined
A data review panel lead by the principal investigator will examine the results of both the CardioSond and CT angiography data to determine the comparative accuracy of the CardioSond in detecting CAD in the study population
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2010-153 | OTHER | Medstar Research Institute | None |