Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2026-02-26 @ 12:45 AM
Study NCT ID:
NCT04755335
Status:
COMPLETED
Last Update Posted:
2025-04-23
First Post:
2021-02-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasonic Perfusion Estimation in Calf Muscle
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D009120', 'term': 'Muscle Cramp'}], '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': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-11-04', 'size': 359215, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-04-15T08:48', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2023-05-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-17', 'studyFirstSubmitDate': '2021-02-02', 'studyFirstSubmitQcDate': '2021-02-10', 'lastUpdatePostDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Aim 1: Determine the efficacy of ultrasonic perfusion imaging for early detection of PAD. The goal is to quantify the perfusion of cuff muscle in patients with lower leg claudication and compare the results to those obtained in healthy individuals', 'timeFrame': '4 yeas', 'description': 'Perfusion density of the cuff muscle will be quantified by the new automatic ultrasound microvessel quantification technique and the resulting measurements will measure the outcome of this part of the study.'}], 'secondaryOutcomes': [{'measure': 'Aim 2: Determine the efficacy of ultrasonic perfusion imaging for assessment of treatment response in PAD patients. The goal is to quantify the perfusion of the cuff muscle in PAD patients in 3 time points, 6 months, and every year after treatment.', 'timeFrame': '5 years', 'description': 'At each time point after the treatment, the perfusion density of the cuff muscle will be quantified by the new automatic ultrasound microvessel quantification technique and the resulting measurements will measure the outcome of this part of the study.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Blood flow', 'Blood Vessel', 'Ischemia', 'Calf muscle pain', 'Vascular', 'Ultrasound', 'Intermitant claudication', 'Cramp'], 'conditions': ['Peripheral Arterial Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the potential of ultrasound perfusion imaging technique for assessing the progression of peripheral arterial disease (PAD) and monitoring its response to therapy by measuring changes in microvessel alterations and perfusion variations.', 'detailedDescription': 'The clinical manifestations of peripheral arterial disease (PAD), regardless of etiology, are due to a lack of blood flow to the musculature relative to its metabolism, which results in pain in the affected muscle groups. PAD affecting the lower extremities causes claudication, cramping pain in the calf muscle, thigh or hip muscle induced by exercise. The initial test for evaluation of patients with claudication is ankle brachial index (ABI).\n\nTherefore, a non-invasive and affordable US technique that can quantify blood perfusion and microvasculature density, without using contrast agent, will improve PAD detection in early stage and can monitor the disease progress as well as the treatment response. The investigators anticipate that our new cost-effective and non-invasive ultrasound perfusion technique offers a quantitative imaging of perfusion that would help separating PAD from non-PAD and monitor the disease progression and treatment response.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subject population will include n=300 symptomatic patients with claudication, at risk for PAD (150 abnormal ABI and 100 with normal ABI), male and female, age ≥18 years and are referred Mayo Clinic Vascular Center due to claudication or atypical leg symptoms for ABI examination. In addition to comparing to the group of Normal (symptomatic patients with normal resting and exercise ABI), the study will also include 50 healthy volunteers with normal ABI and with no history of smoking cardiovascular and metabolic disorders, including diabetes mellitus.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female volunteers \\> 18 years old.\n* Male and female volunteers with symptom of claudication and suspected peripheral arterial disease (PAD) who are scheduled for vascular testing.\n\nExclusion Criteria:\n\n* Patients with gangrene.\n* Patients with lower leg amputation.\n* Having ulcer and any health condition that does not allow proper use of ultrasound scanning.\n* People considered in "vulnerable" populations.'}, 'identificationModule': {'nctId': 'NCT04755335', 'briefTitle': 'Ultrasonic Perfusion Estimation in Calf Muscle', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Ultrasonic Perfusion Imaging of Peripheral Vascular Disease', 'orgStudyIdInfo': {'id': '19-002559'}, 'secondaryIdInfos': [{'id': 'R01HL148664', 'link': 'https://reporter.nih.gov/quickSearch/R01HL148664', 'type': 'NIH'}, {'id': '5R01HL148664-02', 'link': 'https://reporter.nih.gov/quickSearch/5R01HL148664-02', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Early detection of PAD, assessment of the disease progression and treatment response', 'description': 'The objective of this arm of the study is to evaluate the potentials of Ultrasound Perfusion imaging technique for early detection of peripheral arterial disease in patients and assess the disease progression and monitor the treatment response.\n\nThe investigators anticipate that our new cost-effective and non-invasive ultrasound perfusion technique offers a quantitative perfusion estimation of calf muscle that would separate PAD from non-PAD and help early detection of PAD and would help monitoring the disease progression and treatment response.', 'interventionNames': ['Diagnostic Test: Ultrasound']}, {'label': 'Healthy volunteers', 'description': 'A group of healthy volunteers ages 18 and above with no history of smoking, cardiovascular, diabetes or surgery on legs.', 'interventionNames': ['Diagnostic Test: Ultrasound']}], 'interventions': [{'name': 'Ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'In this project, The investigators will use Alpinion ECUBE-12R (Alpinion, Bothell, WA) US platform. This state-of-the-art research US machine provides beam formed as well as Plane-Wave imaging options that allow high frame rate imaging. The investigators have characterized the acoustic output of this system for safe human studies and obtained the IRB approval for human studies. It should be noted that our technique is not limited to the Alpinion system; the investigators can also use other US systems, such as Verasonics, Vantage, (Redmond, WA). This technique can be adapted to other modern US machines in the future.', 'armGroupLabels': ['Early detection of PAD, assessment of the disease progression and treatment response', 'Healthy volunteers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Azra Alizad, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Azra Alizad', 'investigatorAffiliation': 'Mayo Clinic'}}}}