Phase 3 Safety and Imaging Study of AI-700 in Patients With Suspected Coronary Artery Disease Und… (NCT00156845) | Clinical Trial Compass
CompletedPhase 3
Phase 3 Safety and Imaging Study of AI-700 in Patients With Suspected Coronary Artery Disease Undergoing Coronary Angiography
United States450 participantsStarted 2003-12
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
* Candidates with significant cardiovascular or pulmonary structural and/or functional abnormality, or in whom visualization of the left ventricle was not adequate for evaluation of cardiac function during the Exclusion ECHO, were to be ineligible to participate in the study.
* Patients who had a history of MI of non-CAD etiology or who exhibited n…
What they're measuring
1
Accuracy, sensitivity, and specificity of AI-700 ECHO in assessing CAD
2
Safety of AI-700 administered IV to suspected CAD patients