Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2026-01-05 @ 5:16 PM
Study NCT ID:
NCT00669851
Status:
COMPLETED
Last Update Posted:
2008-05-01
First Post:
2008-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acquiring Consensus for Contrast Echocardiography System Settings - ACCESS Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D006331', 'term': 'Heart Diseases'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C108042', 'term': 'perfluorobutane'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'statusVerifiedDate': '2008-04', 'completionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-04-29', 'studyFirstSubmitDate': '2008-04-29', 'studyFirstSubmitQcDate': '2008-04-29', 'lastUpdatePostDateStruct': {'date': '2008-05-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Image quality of echocardiographic data collected via several ultrasound imaging platforms'}, {'measure': 'For Cohort B, the duration of MCE following the first 0.04 mL/kg dose of AI-700'}, {'measure': 'Safety of AI-700 administered IV to healthy volunteers and suspected CAD patients'}]}, 'conditionsModule': {'keywords': ['coronary artery disease', 'echocardiography', 'cardiac imaging', 'heart disease', 'ultrasound contrast agent', 'myocardial contrast enhancement', 'myocardial perfusion'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.acusphere.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This study evaluated and optimized settings for, and evaluated the performance of, AI-700-enhanced echocardiographic imaging on several ultrasound imaging platforms, as well as collected additional safety data for AI-700 in healthy volunteers and stable cardiac patients.', 'detailedDescription': 'Because the quality of AI-700-enhanced images is in part determined by the ultrasound (US) settings selection, the continuing study of different imaging modes and/or techniques is required in order to provide US settings recommendations for the many available systems. Therefore AI-700-enhanced imaging was performed in this study using imaging platforms and modes not previously tested and the AI-700 dose and administration methods employed in previous Phase 3 studies.\n\nTwo cohorts of subjects were studied at each site. Enrollment commenced with Cohort A and included normal (healthy) volunteers and stable cardiac patients. Settings optimization was performed in Cohort A using a single platform and real-time imaging. If the Sponsor agreed that the images and settings acquired in Cohort A were acceptable, the site was authorized to begin enrollment in Cohort B using the platform and settings that were defined in Cohort A. Authorized sites enrolled stable cardiac patients in Cohort B; no healthy volunteers were studied. For Cohort B subjects, the first 0.04 mL/kg dose of AI 700 was used to evaluate real-time imaging with the settings defined in Cohort A. The second dose of AI-700 for Cohort B subjects may have been used to confirm the data obtained with the first dose, or to explore imaging in a second mode (e.g. 3D/4D) and/or using real-time, high mechanical index triggered imaging on a second platform.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* For Cohort A, men and non-pregnant/non-lactating women in good health who are 18 to 70 years of age and who have a low chance of CAD will be enrolled.\n* For Cohort B, men and non-pregnant/non-lactating women in good health who are 18-70 years of age who have had a prior MI and/or coronary artery revascularization intervention \\>90 days before AI-700 administration, without new or recurrent angina will be enrolled.\n\nExclusion Criteria:\n\n* Healthy volunteers in Cohort A who have or have had any of the following conditions will be excluded from the study: clinically significant intra-cardiac shunts or any other cardiovascular structural and/or severe functional abnormalities on the Qualification Echo, unless deemed not clinically relevant by the Investigator and subsequently approved by the Sponsor; ejection fraction (EF, estimated from the Qualification Echo) that is ≤55% (outside normal range), history or clinical manifestations of significant mental illness or significant pulmonary, hematological, renal, hepatic, central nervous, cardiovascular, genitourinary, or gastrointestinal disorders, or diabetes; history of any major surgical procedure within 90 days of Screening/Baseline; body mass index (BMI) \\>35; sitting systolic blood pressure \\<90 mmHg or \\>150 mmHg, diastolic blood pressure \\<50 mmHg or \\>95 mmHg, or a pulse rate \\<45 bpm or \\>90 bpm; oxygen saturation \\<92% at rest; and inadequate image quality on the Qualification Echo. Other exclusion criteria include: participation in an investigational drug/device study within 30 days prior to dosing (90 days for UK sites), participation in a previous clinical trial of AI-700, non-seasonal asthma within the past 3 years or recent seasonal asthma requiring prescription medication, frequent (\\>5/min) premature ventricular or atrial contractions (PVC, PAC), and any ≥2nd AV block, bundle branch block (BBB), or rhythm abnormality.\n* Stable cardiac patients in Cohorts A or B who have had any of the following conditions will be excluded from the study: any clinically unstable condition or major surgery within 30 days prior to Screening/Baseline (including but not limited to severe arterial hypertension, pulmonary hypertension, or any increase in pulmonary pressures due to increased pulmonary resistance, hypotension, bradycardia, tachycardia, unstable angina); cerebrovascular accident or transient ischemic attack within 90 days prior to dosing; congestive heart failure graded as New York Heart Association Class 3 or 4 within 90 days prior to dosing; significant left main CAD (≥50% stenosis); moderate to severe chronic obstructive pulmonary disease (COPD) within 6 months prior to dosing; or oxygen saturation \\<90% at rest; and inadequate image quality on the Qualification Echo. Candidates with clinically significant intra-cardiac shunts or any other cardiovascular structural and/or severe functional abnormalities per the Qualification Echo \\[including intra cardiac shunts; uncorrected congenital heart disease (i.e., severe valvular disease; large amount of pericardial effusion\\], EF (as estimated from the Qualification Echo) of \\<40%; are also not eligible to participate. Subjects who exhibit new or changing ECG abnormalities at any time between Screening and AI-700 dosing will be similarly excluded. Other exclusion criteria include: participation in an investigational drug/device study within 30 days prior to dosing (90 days for UK sites), participation in a previous clinical trial of AI-700, non-seasonal asthma within the past 3 years or recent seasonal asthma requiring prescription medication, organ transplant or end-stage organ failure, and active seizure disorder. Candidates will also be excluded for uncontrolled atrial fibrillation, frequent (\\>5/min) PVCs or PACs, history of prolonged QT/QTc (\\>500 msec), use of automatic implantable cardioverter/defibrillator, and any ≥2nd AV block, BBB, or rhythm abnormality that has not been evaluated and treated by a specialist or for which current treatment is not adequately effective to the extent that subject safety is assured.'}, 'identificationModule': {'nctId': 'NCT00669851', 'briefTitle': 'Acquiring Consensus for Contrast Echocardiography System Settings - ACCESS Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Acusphere'}, 'officialTitle': 'A Phase 3, International, Exploratory, Open-Label, Multicenter, Dual-Injection, Echocardiographic Imaging Settings and Safety Study of AI-700 in Normal Volunteers and Stable Cardiac Patients', 'orgStudyIdInfo': {'id': 'AI-700-34'}}, 'armsInterventionsModule': {'interventions': [{'name': 'AI-700', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02472', 'city': 'Watertown', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Acusphere, Inc.', 'geoPoint': {'lat': 42.37093, 'lon': -71.18283}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Acusphere', 'class': 'INDUSTRY'}}}}