Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2026-01-02 @ 3:02 PM
Study NCT ID:
NCT00918866
Status:
COMPLETED
Last Update Posted:
2020-11-24
First Post:
2009-06-04
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Commercial DEFINITY® to Monitor the Effects of the Heart's Pulmonary Artery Pressure
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011660', 'term': 'Pulmonary Heart Disease'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C042852', 'term': 'perflutren'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dana.washburn@lantheus.com', 'phone': '978-671-8686', 'title': 'Dana Washburn, M.D.', 'organization': 'Lantheus Medical Imaging'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Through 32 hours', 'eventGroups': [{'id': 'EG000', 'title': 'Low Pulmonary Arterial Pressure', 'description': 'Subjects with pulmonary arterial pressure (PAP) of \\< or = to 35 mmHg.', 'otherNumAtRisk': 16, 'otherNumAffected': 4, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Elevated Pulmonary Arterial Pressure', 'description': 'Subjects with a PAP of \\> or = to 35 mmHg.', 'otherNumAtRisk': 16, 'otherNumAffected': 5, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Neck Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}], 'frequencyThreshold': '0.5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change in Pulmonary Artery Pressure Change From 1 Minute Pre-dose to 31 - 35 Minutes Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Pulmonary Arterial Pressure', 'description': 'Subjects with pulmonary arterial pressure (PAP) of \\< or = to 35 mmHg.'}, {'id': 'OG001', 'title': 'Elevated Pulmonary Arterial Pressure', 'description': 'Subjects with a PAP of \\> or = to 35 mmHg.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.9', 'spread': '18.03', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '10.25', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '31-35 minutes minus baseline', 'description': 'Percent change in pulmonary atery pressure change from immediately pre-dose to 31 - 35 minutes post dose', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per the protocol'}, {'type': 'SECONDARY', 'title': 'Immunology Panel- Complement 3A (C3A)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Pulmonary Arterial Pressure', 'description': 'Subjects with pulmonary arterial pressure (PAP) of \\< or = to 35 mmHg.'}, {'id': 'OG001', 'title': 'Elevated Pulmonary Arterial Pressure', 'description': 'Subjects with a PAP of \\> or = to 35 mmHg.'}], 'classes': [{'categories': [{'measurements': [{'value': '-45.80', 'spread': '338.14', 'groupId': 'OG000'}, {'value': '-38.20', 'spread': '414.86', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Out to 70 minutes', 'description': 'Evaluate the Immunology Panel after the administration of DEFINITY', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Immunology Panel- Complement 5A(C5A)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Pulmonary Arterial Pressure', 'description': 'Subjects with pulmonary arterial pressure (PAP) of \\< or = to 35 mmHg.'}, {'id': 'OG001', 'title': 'Elevated Pulmonary Arterial Pressure', 'description': 'Subjects with a PAP of \\> or = to 35 mmHg.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.95', 'spread': '3.56', 'groupId': 'OG000'}, {'value': '0.78', 'spread': '4.55', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Out to 70 minutes', 'description': 'Evaluate the Immunology Panel after the administration of DEFINITY', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Immunology Panel- Interleuken-6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Pulmonary Arterial Pressure', 'description': 'Subjects with pulmonary arterial pressure (PAP) of \\< or = to 35 mmHg.'}, {'id': 'OG001', 'title': 'Elevated Pulmonary Arterial Pressure', 'description': 'Subjects with a PAP of \\> or = to 35 mmHg.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.31', 'spread': '1.46', 'groupId': 'OG000'}, {'value': '0.15', 'spread': '2.11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Out to 70 minutes', 'description': 'Evaluate the Immunology Panel after the administration of DEFINITY', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Immunology Panel- Tryptase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Pulmonary Arterial Pressure', 'description': 'Subjects with pulmonary arterial pressure (PAP) of \\< or = to 35 mmHg.'}, {'id': 'OG001', 'title': 'Elevated Pulmonary Arterial Pressure', 'description': 'Subjects with a PAP of \\> or = to 35 mmHg.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.24', 'spread': '0.82', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '1.46', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Out to 70 minutes', 'description': 'Evaluate the Immunology Panel after the administration of DEFINITY', 'unitOfMeasure': 'ug/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Low Pulmonary Arterial Pressure', 'description': 'Subjects with pulmonary arterial pressure (PAP) of \\< or = to 35 mmHg.'}, {'id': 'FG001', 'title': 'Elevated Pulmonary Arterial Pressure', 'description': 'Subjects with a PAP of \\> or = to 35 mmHg.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'participants were recruited from hospitals and clinics in the USA between July 2009 and December 2009', 'preAssignmentDetails': 'There were no randomization procedures or other pre-assignment requirements in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Low Pulmonary Arterial Pressure', 'description': 'Subjects with pulmonary arterial pressure (PAP) of \\< or = to 35 mmHg.'}, {'id': 'BG001', 'title': 'Elevated Pulmonary Arterial Pressure', 'description': 'Subjects with a PAP of \\> or = to 35 mmHg.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.9', 'spread': '10.8', 'groupId': 'BG000'}, {'value': '57.4', 'spread': '15.1', 'groupId': 'BG001'}, {'value': '57.2', 'spread': '12.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Pulmonary artery pressure 1 minute pre-dose', 'classes': [{'categories': [{'measurements': [{'value': '30.4', 'spread': '3.38', 'groupId': 'BG000'}, {'value': '50.9', 'spread': '10.31', 'groupId': 'BG001'}, {'value': '40.7', 'spread': '12.89', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-06', 'studyFirstSubmitDate': '2009-06-04', 'resultsFirstSubmitDate': '2010-12-17', 'studyFirstSubmitQcDate': '2009-06-10', 'lastUpdatePostDateStruct': {'date': '2020-11-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-06-13', 'studyFirstPostDateStruct': {'date': '2009-06-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change in Pulmonary Artery Pressure Change From 1 Minute Pre-dose to 31 - 35 Minutes Post Dose', 'timeFrame': '31-35 minutes minus baseline', 'description': 'Percent change in pulmonary atery pressure change from immediately pre-dose to 31 - 35 minutes post dose'}], 'secondaryOutcomes': [{'measure': 'Immunology Panel- Complement 3A (C3A)', 'timeFrame': 'Out to 70 minutes', 'description': 'Evaluate the Immunology Panel after the administration of DEFINITY'}, {'measure': 'Immunology Panel- Complement 5A(C5A)', 'timeFrame': 'Out to 70 minutes', 'description': 'Evaluate the Immunology Panel after the administration of DEFINITY'}, {'measure': 'Immunology Panel- Interleuken-6', 'timeFrame': 'Out to 70 minutes', 'description': 'Evaluate the Immunology Panel after the administration of DEFINITY'}, {'measure': 'Immunology Panel- Tryptase', 'timeFrame': 'Out to 70 minutes', 'description': 'Evaluate the Immunology Panel after the administration of DEFINITY'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Phase 4', 'DEFINITY®', 'hemodynamics', 'pulmonary artery pressure'], 'conditions': ['Pulmonary Heart Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical research is to learn if DEFINITY® 416 will cause any adverse effects during Right Heart Catheterization. This research was requested by the FDA.', 'detailedDescription': 'This Phase IV safety study will provide safety data on potential systemic and pulmonary hemodynamic effects caused by the administration of DEFINITY® in patients who are to undergo right heart cardiac catheterization for clinical reasons. Using a right heart catheter for direct measurements of pulmonary artery hemodynamics will allow accurate assessments of potential alterations of the pulmonary vasculature. This will be further investigated by the inclusion of two patient populations, one with a baseline pulmonary artery pressure \\< 35 mmHg, and one with elevated baseline pulmonary artery pressure. The addition of immune parameter measurements will assess a potential link between systemic and pulmonary alterations and potential immune reactions following DEFINITY® administration.\n\nThe inclusion of patients in this study is not based on a required echocardiogram with DEFINITY® administration because patients would be exposed to an unjustifiable risk of invasive right heart catheterization and are unlikely to consent to such a procedure. Therefore, patients undergoing heart catheterization for clinical reasons, or patients who are undergoing pulmonary artery hemodynamic assessments will be enrolled and receive DEFINITY® in this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Appropriate candidate scheduled to undergo right heart catheterization and measurement of pulmonary artery hemodynamics for clinical reasons\n* Be male or female above the age of 18\n* Female patients who no longer have child-bearing potential\n* Women of Child-Bearing Potential(WOCBP) who:\n\n 1. are not pregnant and have been using an adequate and medically approved method of contraception\n 2. have a negative urine pregnancy test\n* Be able and willing to communicate effectively with study center personnel.\n\nExclusion Criteria:\n\n* Women who are pregnant or lactating\n* Known hypersensitivity or contraindication to or greater heart block\n* Previous heart transplant\n* Known right-to-left shunt (including atrial septal defect)\n* Severe pulmonary artery hypertension (i.e., \\> 75 mmHg\n* Current uncontrolled ventricular tachycardia\n* Second-degree or greater heart block\n* Any contraindications for the use of a right heart catheter'}, 'identificationModule': {'nctId': 'NCT00918866', 'briefTitle': "A Study of Commercial DEFINITY® to Monitor the Effects of the Heart's Pulmonary Artery Pressure", 'organization': {'class': 'INDUSTRY', 'fullName': 'Lantheus Medical Imaging'}, 'officialTitle': 'A Phase IV, Open-Label Safety Evaluation of the Effect of DEFINITY® on Pulmonary Artery Hemodynamics in Patients With Normal and Increased Pulmonary Artery Pressure', 'orgStudyIdInfo': {'id': 'DMP 115-416'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low Pulmonary Arterial Pressure', 'description': 'Subjects with pulmonary arterial pressure (PAP) of \\< or = to 35 mmHg.', 'interventionNames': ['Drug: Definity']}, {'type': 'EXPERIMENTAL', 'label': 'Elevated Pulmonary Arterial Pressure', 'description': 'Subjects with a PAP of \\> or = to 35 mmHg.', 'interventionNames': ['Drug: Definity']}], 'interventions': [{'name': 'Definity', 'type': 'DRUG', 'otherNames': ['Perflutren Lipid Microsphere'], 'description': 'one bolus dose of Definity per intravenous injection, 30-60 second injection, dose value calculation = maximum of 10 microliter/kg patient weight', 'armGroupLabels': ['Elevated Pulmonary Arterial Pressure', 'Low Pulmonary Arterial Pressure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern Memorial Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '55426', 'city': 'Saint Louis Park', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Methodist Hospital', 'geoPoint': {'lat': 44.9483, 'lon': -93.34801}}, {'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Cardiovascular Consultants', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '07666', 'city': 'Teaneck', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Holy Name Hospital', 'geoPoint': {'lat': 40.8976, 'lon': -74.01597}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health and Sciences University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '77555', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas Medical Branch at Galveston', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}], 'overallOfficials': [{'name': 'Veronica Lee, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Lantheus Medical Imaging'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lantheus Medical Imaging', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}