Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-26 @ 12:57 AM
Study NCT ID:
NCT01408134
Status:
TERMINATED
Last Update Posted:
2013-03-29
First Post:
2011-07-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Viability Imaging in Volumetric Angiography (VIVA 1)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'whyStopped': 'PI/Project director no longer at facility', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-28', 'studyFirstSubmitDate': '2011-07-28', 'studyFirstSubmitQcDate': '2011-08-02', 'lastUpdatePostDateStruct': {'date': '2013-03-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inter-reader variability of myocardial viability', 'timeFrame': 'day One', 'description': 'To define inter-reader variability of myocardial viability imaging within the first pass and delayed enhancement cardiac CT perfusion imaging, specifically:\n\n* Per myocardial segment binary visual estimation of the presence/absence of contrast enhancement on either a first pass or 10-minute delayed CT scan.\n* Myocardial enhancement (hyper and hypo-enhancement) will be evaluated using a binary assessment for estimation of the involved myocardial segments on delayed images. Regional wall motion will be assessed qualitatively using a 4 point scale: normal, hypokinetic, akinetic, dyskinetic.'}, {'measure': 'DE CT image quality', 'timeFrame': 'day One', 'description': 'To evaluate DE CT image quality using a consensus DECT protocol'}], 'secondaryOutcomes': [{'measure': 'Scan and patient factors related to the image quality', 'timeFrame': 'day One', 'description': 'The secondary endpoint will be to describe the scan and patient factors related to the image quality on myocardial CT perfusion imaging'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Inter-reader variability of myocardial viability imaging'], 'conditions': ['Myocardial Scarring']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is twofold:\n\n1. To define inter-reader variability of myocardial viability imaging within the first pass and delayed enhancement cardiac CT perfusion imaging\n2. To evaluate DE CT image quality using a consensus DECT protocol', 'detailedDescription': 'The presence of myocardial scar using radionuclide or magnetic resonance imaging techniques indicates myocardial segments with a reduced likelihood of functional recovery following myocardial revascularization. Preliminary evidence suggests that multi-detector CT (MDCT) angiography also can detect irreversible myocardial scarring through the detection of regions of delayed hyperenhancement (DE) of the myocardium.1-4 However, existing studies have been performed in single centers, and the reproducibility, and impact of this modality on recovery of myocardial function is unknown. In this study, the investigators propose a single-center trial using a standardized MDCT DE protocol among patients scheduled for clinical cardiac CT with planned reoperative surgical. The primary endpoint will be characteristics of DE imaging of the myocardium including its inter-reader variability and factors associated with image quality. These findings will further our understanding of the role of DE MDCT for the detection of myocardial viability.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eligible patients will be adults, ages 18 and above with:\n\n 1. Known CAD with prior MI based upon clinical history or electrocardiographic criteria\n 2. Planned redo-surgical myocardial revascularization\n 3. Referred for CT (and eligible) for pre-op substernal mapping/coronary artery evaluation\n\nExclusion Criteria:\n\n1. Inability to provide informed consent\n2. Allergy to iodinated contrast media (unless pre-medicated with medical prophylaxis)\n3. Chronic kidney disease manifested by a serum creatinine \\>1.5 mg/dL, an estimated creatinine clearance \\<50 ml/kg/min or on dialysis\n4. Currently reporting or evaluated in NYHA class IV heart failure'}, 'identificationModule': {'nctId': 'NCT01408134', 'acronym': 'VIVA 1', 'briefTitle': 'Viability Imaging in Volumetric Angiography (VIVA 1)', 'organization': {'class': 'OTHER', 'fullName': 'Medstar Health Research Institute'}, 'officialTitle': 'Viability Imaging in Volumetric Angiography (VIVA 1): A Single Center Trial of the Detection of Delayed Hyperenhancement on CT Angiography', 'orgStudyIdInfo': {'id': 'VIVA 1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'DE CT', 'type': 'OTHER', 'description': 'Delayed scan (per VIVA protocol): The delayed scan will be performed 10 minutes after contrast second contrast bolus complete using axial acquisition at 100 kVp. Scan length will be limited to the cardiac structures.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Washington Hospital Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medstar Health Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}