Ignite Creation Date:
2025-12-24 @ 7:54 PM
Ignite Modification Date:
2026-02-17 @ 11:54 PM
Study NCT ID:
NCT02791204
Status:
RECRUITING
Last Update Posted:
2025-02-03
First Post:
2016-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SPECT/CT Imaging of Skeletal Muscle Perfusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-30', 'studyFirstSubmitDate': '2016-05-25', 'studyFirstSubmitQcDate': '2016-05-31', 'lastUpdatePostDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of effect of percutaneous revascularization treatment measured by change in lower extremity skeletal muscle perfusion before and after treatment using quantitative SPECT/CT imaging of the lower extremities.', 'timeFrame': 'patients will be assessed prior to the revascularization procedure (baseline) and a second time 1-3 days following revascularization.'}, {'measure': 'Assessment of lower extremity skeletal muscle perfusion in healthy control subjects compared to patients with peripheral arterial disease and diabetes using quantitative SPECT/CT imaging.', 'timeFrame': 'baseline'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Peripheral Arterial Disease', 'Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'This study will use SPECT/CT imaging to assess the effect of percutaneous revascularization treatments in patients with Peripheral arterial disease and diabetes mellitus, in whom the disease can progress more quickly than in patients without diabetes.', 'detailedDescription': 'Peripheral arterial disease (PAD) is a progressive atherosclerotic disease of the lower limbs that affects 8 to 10 million Americans, and is more prevalent and progresses more quickly in patients with diabetes mellitus (DM). There is a critical need for a standard non-invasive approach to assess response to treatment by three-dimensional (3D) perfusion to vascular territories of the feet in PAD patients. Assessing the response to treatment is particularly important in DM patients, who suffer from poor distal runoff and often require more distal revascularization to achieve limb salvage.\n\nIn this clinical study, the investigators will evaluate lower extremity skeletal muscle perfusion in the feet of healthy controls and PAD patients who are undergoing revascularization using conventional sodium iodide SPECT/CT imaging, as well as dynamic SPECT/CT imaging with a unique cadmium zinc telluride (CZT) system.\n\nHealthy control subjects will be recruited from Yale University and the greater New Haven area. In addition to healthy control subjects, 35 PAD patients with previously diagnosed diabetes will be recruited from Vascular Surgery and Interventional Cardiology at Yale-New Haven Hospital. Patients who are undergoing revascularization procedures will be identified and asked to participate in the imaging study prior to their revascularization procedure and will be imaged once again 1-3 days following revascularization, prior to hospital discharge.\n\nSubjects will undergo resting perfusion imaging of the feet using two separate SPECT/CT systems. They will be injected with a low dose radiotracer. In healthy control subjects, arterial blood will be continuously sampled from the radial artery for calculation of a blood input function and K1 values for foot angiosomes. Additionally, we will sample heated venous "arterialized" blood from a hand vein retrograde to evaluate the potential for heated venous blood in the calculation of a blood input function, thus eliminating the need for arterial access in future PAD patient studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '* healthy control subjects will be enrolled for this study.\n* PAD patients with diabetes who are undergoing revascularization procedures\n* patients undergoing clinically indicated myocardial perfusion imaging study', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for Healthy Control Population:\n\n1. At least 18 years of age\n2. Normal (0.9-1.2) Ankle Brachial Index\n\nInclusion Criteria for patients undergoing clinically indicated myocardial perfusion study:\n\n1\\) At least 18 years of age 2) scheduled for stress myocardial perfusion imaging study for clinically indicated reason\n\n-Inclusion Criteria for PAD Patient Population:\n\n1. At least 18 years of age\n2. Evidence of significant obstructive disease for one or multiple lower extremity arteries, as identified by CT angiography, ultrasound, or MR imaging or an abnormal ankle-brachial index or toe-brachial index\n3. Previously diagnosed diabetes mellitus (type I or II), based on any of the following criteria: fasting plasma glucose great than 126 mg/dl on 2 separate occasions, glycated hemoglobin (HbA1c) greater than 6.5% on 2 separate occasions, fasting plasma glucose greater than 200 mg/dl 2 hours following an oral glucose tolerance test on 2 separate occasions, or fasting plasma glucose and HbA1c above normal limits on same visit.\n4. scheduled for revascularization due to obstructive blood flow in the lower extremities.\n\nExclusion Criteria for Healthy Control Population:\n\n1. Unable to give informed consent\n2. Enrolled in another trial\n3. Preexisting medical conditions affecting the vascular system including, but not limited to: Coronary Artery Disease, Peripheral Arterial Disease, diabetes, cancer, hypertension, history of smoking\n4. Pregnant or nursing\n\nExclusion Criteria for PAD Patient Population:\n\n1. Unable to give informed consent or follow-up\n2. Enrolled in another trial\n\nExclusion Criteria for patients undergoing clinically indicated myocardial perfusion study:\n\n1\\) Unable to give informed consent'}, 'identificationModule': {'nctId': 'NCT02791204', 'briefTitle': 'SPECT/CT Imaging of Skeletal Muscle Perfusion', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'SPECT/CT Imaging of Skeletal Muscle Perfusion in Healthy Control Subjects and Patients With Peripheral Arterial Disease: Pilot Clinical Study', 'orgStudyIdInfo': {'id': '1603017342'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants with PAD', 'description': 'Subjects will undergo resting perfusion imaging of the feet using two separate SPECT/CT systems. Subjects will be injected with a low dose radioisotope. Heated venous blood sampling will be obtained.', 'interventionNames': ['Device: SPECT/CT imaging following revascularization procedures']}, {'label': 'Controls', 'description': 'Subjects will undergo resting perfusion imaging of the feet using two separate SPECT/CT systems. Subjects will be injected with a low dose radioisotope. In addition to heated venous blood sampling, arterial blood will be continuously sampled from the radial artery for calculation of a blood input function and K1 values for foot angiosomes.', 'interventionNames': ['Device: SPECT/CT imaging']}], 'interventions': [{'name': 'SPECT/CT imaging following revascularization procedures', 'type': 'DEVICE', 'description': 'Subjects will undergo resting perfusion imaging of the feet using two separate SPECT/CT systems. Subjects will be injected with a low dose radioisotope. Heated venous blood sampling will be obtained.', 'armGroupLabels': ['Participants with PAD']}, {'name': 'SPECT/CT imaging', 'type': 'DEVICE', 'description': 'Subjects will undergo resting perfusion imaging of the feet using two separate SPECT/CT systems. Subjects will be injected with a low dose radioisotope. In addition to heated venous blood sampling, arterial blood will be continuously sampled from the radial artery for calculation of a blood input function and K1 values for foot angiosomes.', 'armGroupLabels': ['Controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Albert J Sinusas, MD', 'role': 'CONTACT', 'email': 'albert.sinusas@yale.edu', 'phone': '203-785-5005'}, {'name': 'Donna McMahon', 'role': 'CONTACT', 'email': 'donna.mcmahon@yale.edu'}], 'facility': 'Yale-New Haven Hospital', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'centralContacts': [{'name': 'Albert J. Sinusas, MD', 'role': 'CONTACT', 'email': 'albert.sinusas@yale.edu', 'phone': '203-785-5005'}, {'name': 'Donna McMahon', 'role': 'CONTACT', 'email': 'donna.mcmahon@yale.edu', 'phone': '203-785-5005'}], 'overallOfficials': [{'name': 'Albert J. Sinusas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Illinois at Urbana-Champaign', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}