Ignite Creation Date:
2025-12-24 @ 10:39 PM
Ignite Modification Date:
2026-02-25 @ 11:03 PM
Study NCT ID:
NCT03265535
Status:
UNKNOWN
Last Update Posted:
2023-04-13
First Post:
2017-08-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of a Single Rest-Stress Imaging Protocol for Myocardial Perfusion Imaging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-06-06', 'releaseDate': '2023-12-17'}], 'estimatedResultsFirstSubmitDate': '2023-12-17'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'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': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-09-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-11', 'studyFirstSubmitDate': '2017-08-25', 'studyFirstSubmitQcDate': '2017-08-25', 'lastUpdatePostDateStruct': {'date': '2023-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stress MBF', 'timeFrame': 'Single session (<2 hours)', 'description': 'Difference in stress myocardial blood flow measured by the single-scan two-injection protocol versus conventional single-scan single-injection stress protocol'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Coronary Artery Disease', 'Myocardial Ischemia']}, 'descriptionModule': {'briefSummary': 'We propose a single-scan two-injection myocardial perfusion imaging protocol using ammonia. Subjects will undergo single-scan two-injection imaging as well as regular stress single-scan single-injection protocol and the myocardial blood flow of both techniques will be compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients of the Massachusetts General Hospital', 'healthyVolunteers': True, 'eligibilityCriteria': 'Healthy Volunteers:\n\nInclusion Criteria:\n\n* Subjects must be ≥30 and ≤75 years of age;\n* Subjects must provide informed consent prior to study procedures;\n\nExclusion Criteria:\n\n* History of CAD, including:\n* Prior abnormal myocardial perfusion study\n* History of MI\n* History of angina\n* Coronary artery obstruction \\>50% on CTA and/or angiography\n* Left ventricular ejection fraction \\<50%\n* Any relative or absolute contraindication to adenosine stress, including:\n* 2nd or 3rd degree heart block\n* Bradycardia (HR\\<50 bpm)\n* Recent acute coronary syndrome (ACS)\n* Unstable angina\n* Severe heart failure (left ventricular ejection fraction \\<15%)\n* Ventricular arrhythmia\n* Severe asthma and/or chronic obstructive pulmonary disease (COPD)\n* Baseline hypotension defined as systolic blood pressure \\< 90 mmHg\n* Caffeine intake within 24 hours prior to imaging\n* Current use of theophylline, dipyridamole, or carbamazepine\n* Allergy or intolerance to adenosine\n* Positive serum and/or urine pregnancy test, or lactating, or possibility of pregnancy cannot be ruled out prior to dosing;\n\nSubjects with CAD:\n\nInclusion criteria\n\n* Subjects must be ≥30 and ≤75 years of age;\n* Subjects must provide informed consent prior to study procedures;\n* Abnormal myocardial perfusion study within the past 12 months\n\nExclusion criteria\n\n* Revascularization (percutaneous coronary intervention and/or coronary artery bypass) following last myocardial perfusion study\n* Acute coronary syndrome within 30 days\n* Left ventricular ejection fraction \\<50%\n* Any relative or absolute contraindication to adenosine stress, including:\n* 2nd or 3rd degree heart block\n* Bradycardia (HR\\<50 bpm)\n* Recent acute coronary syndrome (ACS)\n* Unstable angina\n* Severe heart failure (left ventricular ejection fraction \\<15%)\n* Ventricular arrhythmia\n* Severe asthma and/or chronic obstructive pulmonary disease (COPD)\n* Baseline hypotension defined as systolic blood pressure \\< 90 mmHg\n* Caffeine intake within 24 hours prior to imaging\n* Current use of theophylline, dipyridamole, or carbamazepine\n* Allergy or intolerance to adenosine\n* Any clinically significant acute or unstable physical or psychological disease, judged by the investigators, to be incompatible with the study;\n* Radiation exposure exceeds current Radiology Department guidelines (i.e. 50 mSv in the prior 12 months);\n* Female participants only: Positive serum and/or urine pregnancy test, or lactating, or possibility of pregnancy cannot be ruled out prior to dosing;\n* Inability to provide written informed consent;'}, 'identificationModule': {'nctId': 'NCT03265535', 'briefTitle': 'Validation of a Single Rest-Stress Imaging Protocol for Myocardial Perfusion Imaging', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Validation of a Single Rest-Stress Imaging Protocol for Myocardial Perfusion Imaging', 'orgStudyIdInfo': {'id': '2016P002531'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy Volunteers', 'description': 'Subjects without history of coronary artery disease', 'interventionNames': ['Diagnostic Test: Single-Scan Two-Injection Protocol']}, {'label': 'Subjects with coronary artery disease', 'description': 'Subjects with coronary artery disease and abnormal SPECT myocardial perfusion imaging within the last 12 months', 'interventionNames': ['Diagnostic Test: Single-Scan Two-Injection Protocol']}], 'interventions': [{'name': 'Single-Scan Two-Injection Protocol', 'type': 'DIAGNOSTIC_TEST', 'description': 'Single-Scan Two-Injection Protocol', 'armGroupLabels': ['Healthy Volunteers', 'Subjects with coronary artery disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Marina Macdonald-Soccorso, BS', 'role': 'CONTACT', 'phone': '617-643-1967'}], 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Marina Macdonald-Soccorso, BS', 'role': 'CONTACT', 'email': 'MMACDONALD-SOCCORSO@mgh.harvard.edu', 'phone': '617-643-1967'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Gordon Center for Medical Imaging', 'investigatorFullName': 'Georges El Fakhri', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-12-17', 'type': 'RELEASE'}, {'date': '2024-06-06', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Georges El Fakhri, Director, Gordon Center for Medical Imaging, Massachusetts General Hospital'}}}}