Phase 3 Safety and Imaging Study of AI-700 in Patients With Suspected Coronary Artery Disease Undergoing Coronary Angiography

NCT00156845 | Completed Phase 3

• 1 other identifier: AI-700-33
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

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 coronary angiography.

Conditions

Coronary Artery Disease

Keywords

coronary artery disease; ischemia; echocardiography; cardiac imaging; heart disease; myocardial contrast enhancement; myocardial perfusion; wall motion; ultrasound contrast agent

Outcome Measures

Primary Outcomes (2)

• Accuracy, sensitivity, and specificity of AI-700 ECHO in assessing CAD

• Safety of AI-700 administered IV to suspected CAD patients

Interventions

AI-700 contrast-enhanced echocardiography PROCEDURE

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and non-pregnant/non-lactating women with a history of typical or atypical chest pain (angina) who were 18 to 80 years of age and who had recently undergone coronary angiography or were scheduled for coronary angiography within 30 days after AI-700 administration were to be enrolled. Eligible patients must have also undergone SPECT for evaluation of CAD within 45 calendar days prior to AI-700 administration, or be scheduled for an "on-study" SPECT on the same day as AI-700 dosing or an "off-study" SPECT within 15 days following AI-700 dosing.

You may not qualify if:

• Study candidates who have had any of the following conditions were to be excluded from the study: any clinically unstable condition or major surgery within 7 days prior to AI-700 dosing; an acute MI; cerebrovascular accident or transient ischemic attack within 30 days prior to dosing; congestive heart failure graded as New York Heart Association Grade 4 within 3 months prior to dosing; significant left main CAD; previous coronary artery bypass graft; moderate to severe chronic obstructive pulmonary disease; or oxygen saturation \< 90% at rest.
• Patients who had a history of MI of non-CAD etiology or who exhibited new or changing ECG abnormalities at any time between Screening and AI-700 dosing were to be similarly excluded.
• Candidates were to be excluded for uncontrolled atrial fibrillation, frequent premature ventricular or atrial contractions, history of prolonged QT/QTc, use of automatic implantable cardioverter/defibrillator or pacemaker, and any rhythm abnormality that had not been evaluated and treated by a specialist or for which current treatment did not ensure patient safety.
• Candidates who had used methylated xanthines within 24 hours of dosing were also to be excluded. Patients were also to be excluded if aminophylline, theophylline, or dipyridamole were contraindicated according to each agent's product labeling.

Sponsors & Collaborators

• Acusphere: lead

Study Sites (1)

Acusphere, Inc.

Watertown, Massachusetts, 02472, United States

Location

Related Publications (1)

• Senior R, Monaghan M, Main ML, Zamorano JL, Tiemann K, Agati L, Weissman NJ, Klein AL, Marwick TH, Ahmad M, DeMaria AN, Zabalgoitia M, Becher H, Kaul S, Udelson JE, Wackers FJ, Walovitch RC, Picard MH; RAMP-1 and RAMP-2 Investigators. Detection of coronary artery disease with perfusion stress echocardiography using a novel ultrasound imaging agent: two Phase 3 international trials in comparison with radionuclide perfusion imaging. Eur J Echocardiogr. 2009 Jan;10(1):26-35. doi: 10.1093/ejechocard/jen321.

  PMID: 19131498 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Coronary Artery Disease; Ischemia; Heart Diseases

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: December 1, 2003
• Study Completion: June 1, 2006
• Last Updated: July 14, 2006

Record last verified: 2006-07

Locations

US (1)