Ignite Creation Date:
2025-12-24 @ 9:37 PM
Ignite Modification Date:
2026-01-04 @ 7:20 PM
Study NCT ID:
NCT00670332
Status:
TERMINATED
Last Update Posted:
2008-05-01
First Post:
2008-04-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prognostic Assessment of Contrast Echocardiography (PACE 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 773}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': True}, 'statusVerifiedDate': '2008-04', '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': 'The primary outcome variable is the time to first occurrence of the composite outcome (death or confirmed non fatal MI).', 'timeFrame': 'The time between AI 700 ECHO and outcomes data collection will be ≥12 months with an expected average follow-up period of 24 months'}], 'secondaryOutcomes': [{'measure': 'Certain secondary analyses will include revascularizations and CHF.', 'timeFrame': 'The time between AI 700 ECHO and outcomes data collection will be ≥12 months with an expected average follow-up period of 24 months'}]}, 'conditionsModule': {'keywords': ['coronary artery disease', 'echocardiography', 'cardiac imaging', 'heart disease', 'ultrasound contrast agent', 'prognosis'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'This study will demonstrate whether patients with prognostically-significant myocardial abnormalities detected with AI-700 contrast ECHO have a rate of cardiac death or MI that is higher than that of patients with normal AI-700 contrast ECHO.', 'detailedDescription': 'This observational study will investigate the ability of AI-700 contrast ECHO to predict risk of future cardiovascular events occurring in patients who had a recent history of chest pain at the time of ECHO evaluation. Eligible patients were enrolled in either AI-700-32 or AI-700-33, which are completed Phase 3 international, multicenter, open-label, dual-injection studies of the myocardial imaging capabilities and safety of AI-700 administered intravenously in patients with chest pain. In the course of these Phase 3 studies, patients were evaluated with AI-700 contrast ECHO. In addition, eligible patients were to have had an evaluable pharmacologic stress-induced AI-700 ECHO assessment as part of AI-700-32 or AI-700-33.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This observational study will enroll up to 773 patients who participated in either AI-700-32 or AI-700-33 and who were evaluated with AI-700 contrast ECHO at rest and at pharmacologic-induced stress. Approximately 28 international study centers will participate. At the time of AI-700 contrast ECHO (defined as the index date), the patients were to have had a recent history of chest pain and were to meet all eligibility criteria. Chest pain (angina) was defined as either:\n\n* typical chest pain: 1) substernal chest discomfort with a characteristic quality and duration that is 2) provoked by exertion or emotional stress and 3) relieved by rest or nitroglycerin, or\n* atypical chest pain (angina) that meets 2 of the 3 typical chest pain characteristics.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Eligible patients were enrolled in either AI-700-32 or AI-700-33.'}, 'identificationModule': {'nctId': 'NCT00670332', 'acronym': 'PACE', 'briefTitle': 'Prognostic Assessment of Contrast Echocardiography (PACE Study)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Acusphere'}, 'officialTitle': 'Prognostic Assessment of Contrast Echocardiography (PACE Study): An Observational Follow-up Study of Patients With Chest Pain Evaluated With AI-700 Contrast Echocardiography', 'orgStudyIdInfo': {'id': 'AI-700-36'}}, 'contactsLocationsModule': {'locations': [{'zip': '02472', 'city': 'Watertown', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Acusphere', 'geoPoint': {'lat': 42.37093, 'lon': -71.18283}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Acusphere', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Johh F. Cavanaugh', 'oldOrganization': 'Acusphere'}}}}