Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 11:28 PM
Study NCT ID:
NCT00156793
Status:
COMPLETED
Last Update Posted:
2006-07-14
First Post:
2005-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase 3 Imaging and Safety Study of AI-700 in Patients With Suspected Coronary Artery Disease Undergoing SPECT Imaging
Sponsor:
Acusphere
Organization:
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 angiography/left ventriculography (ANGIO/LVG) 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 angiography/left ventriculography (ANGIO/LVG) or single-photon emission computed tomography (SPECT) with clinical outcome as the reference standards.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: