Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00156793
Status:
COMPLETED
Last Update Posted:
2006-07-14
First Post:
2005-09-08
Brief Title:
Phase 3 Imaging and Safety Study of AI-700 in Patients With Suspected Coronary Artery Disease Undergoing SPECT Imaging
Sponsor:
Acusphere
Organization:
Acusphere
Study Overview
Official Title:
A Phase 3 International Multicenter Open Label Dual-Injection Echocardiographic Imaging and Safety Study of AI-700 in Patients With Suspected Ischemic Heart Disease Undergoing Single-Photon Emission Computed Tomography Real-Time Assessment of Myocardial Perfusion With Echocardiography RAMP 1
Status:
COMPLETED
Status Verified Date:
2006-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study was designed to evaluate the ability of AI-700-enhanced rest-stress echocardiography to detect coronary artery disease CAD in patients with suspected ischemic heart disease who are indicated for single-photon emission computed tomography SPECT imaging
Detailed Description:
Assessment of myocardial perfusion has been demonstrated to provide both diagnostic and prognostic value to patients with ischemic heart disease by allowing the clinician to assess the hemodynamic significance of coronary artery disease CAD The primary objective of the clinical development program for AI-700 is to demonstrate the safety and efficacy of AI-700 as an intravenous ultrasound contrast agent in patients with suspected myocardial perfusion defects
The patient population is comprised of patients who are being evaluated for inducible ischemia The primary study objective was to determine the accuracy sensitivity and specificity of AI-700-enhanced echocardiographic imaging for detecting CAD using coronary angiographyleft ventriculography ANGIOLVG or single-photon emission computed tomography SPECT with clinical outcome as the reference standards
The patient population is comprised of patients who are being evaluated for inducible ischemia The primary study objective was to determine the accuracy sensitivity and specificity of AI-700-enhanced echocardiographic imaging for detecting CAD using coronary angiographyleft ventriculography ANGIOLVG or single-photon emission computed tomography SPECT with clinical outcome as the reference standards
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