Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-03-05 @ 6:03 PM
Study NCT ID:
NCT01446094
Status:
UNKNOWN
Last Update Posted:
2017-10-03
First Post:
2011-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnostic Study of Rapid Regadenoson Stress Cardiovascular Magnetic Resonance (CMR) to Detect Coronary Artery Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2019-02-21', 'releaseDate': '2019-01-31'}, {'resetDate': '2019-10-16', 'releaseDate': '2019-09-27'}, {'resetDate': '2021-12-15', 'releaseDate': '2021-11-17'}], 'estimatedResultsFirstSubmitDate': '2019-01-31'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C430916', 'term': 'regadenoson'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-09-29', 'studyFirstSubmitDate': '2011-09-21', 'studyFirstSubmitQcDate': '2011-09-30', 'lastUpdatePostDateStruct': {'date': '2017-10-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-10-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Profile of sensitivity, specificity, and diagnostic accuracy of rapid regadenoson stress CMR.', 'timeFrame': 'Up to 7 days', 'description': 'Evaluate the profile of sensitivity, specificity, and diagnostic accuracy of a rapid regadenoson stress CMR protocol for the detection of \\>= 70% stenosis of a major epicardial coronary artery on invasive coronary angiography.'}], 'secondaryOutcomes': [{'measure': 'Evaluate time for performance of rapid regadenoson stress CMR protocol.', 'timeFrame': 'Up to 7 days', 'description': 'Evaluate duration of time for performance of rapid regadenoson stress CMR protocol in comparison to time for performance of standard regadenoson stress CMR protocol.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Coronary artery disease'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '12573373', 'type': 'BACKGROUND', 'citation': 'Wagner A, Mahrholdt H, Holly TA, Elliott MD, Regenfus M, Parker M, Klocke FJ, Bonow RO, Kim RJ, Judd RM. Contrast-enhanced MRI and routine single photon emission computed tomography (SPECT) perfusion imaging for detection of subendocardial myocardial infarcts: an imaging study. Lancet. 2003 Feb 1;361(9355):374-9. doi: 10.1016/S0140-6736(03)12389-6.'}, {'pmid': '19381280', 'type': 'BACKGROUND', 'citation': 'Kim HW, Klem I, Shah DJ, Wu E, Meyers SN, Parker MA, Crowley AL, Bonow RO, Judd RM, Kim RJ. Unrecognized non-Q-wave myocardial infarction: prevalence and prognostic significance in patients with suspected coronary disease. PLoS Med. 2009 Apr 21;6(4):e1000057. doi: 10.1371/journal.pmed.1000057. Epub 2009 Apr 21.'}, {'pmid': '9240523', 'type': 'BACKGROUND', 'citation': 'Wilke N, Jerosch-Herold M, Wang Y, Huang Y, Christensen BV, Stillman AE, Ugurbil K, McDonald K, Wilson RF. Myocardial perfusion reserve: assessment with multisection, quantitative, first-pass MR imaging. Radiology. 1997 Aug;204(2):373-84. doi: 10.1148/radiology.204.2.9240523.'}, {'pmid': '10736280', 'type': 'BACKGROUND', 'citation': 'Al-Saadi N, Nagel E, Gross M, Bornstedt A, Schnackenburg B, Klein C, Klimek W, Oswald H, Fleck E. Noninvasive detection of myocardial ischemia from perfusion reserve based on cardiovascular magnetic resonance. Circulation. 2000 Mar 28;101(12):1379-83. doi: 10.1161/01.cir.101.12.1379.'}, {'pmid': '11342469', 'type': 'BACKGROUND', 'citation': 'Schwitter J, Nanz D, Kneifel S, Bertschinger K, Buchi M, Knusel PR, Marincek B, Luscher TF, von Schulthess GK. Assessment of myocardial perfusion in coronary artery disease by magnetic resonance: a comparison with positron emission tomography and coronary angiography. Circulation. 2001 May 8;103(18):2230-5. doi: 10.1161/01.cir.103.18.2230.'}, {'pmid': '12860910', 'type': 'BACKGROUND', 'citation': 'Nagel E, Klein C, Paetsch I, Hettwer S, Schnackenburg B, Wegscheider K, Fleck E. Magnetic resonance perfusion measurements for the noninvasive detection of coronary artery disease. Circulation. 2003 Jul 29;108(4):432-7. doi: 10.1161/01.CIR.0000080915.35024.A9. Epub 2003 Jul 14.'}, {'pmid': '16631001', 'type': 'BACKGROUND', 'citation': 'Klem I, Heitner JF, Shah DJ, Sketch MH Jr, Behar V, Weinsaft J, Cawley P, Parker M, Elliott M, Judd RM, Kim RJ. Improved detection of coronary artery disease by stress perfusion cardiovascular magnetic resonance with the use of delayed enhancement infarction imaging. J Am Coll Cardiol. 2006 Apr 18;47(8):1630-8. doi: 10.1016/j.jacc.2005.10.074. Epub 2006 Mar 27.'}, {'pmid': '12882082', 'type': 'BACKGROUND', 'citation': 'Kim RJ, Shah DJ, Judd RM. How we perform delayed enhancement imaging. J Cardiovasc Magn Reson. 2003 Jul;5(3):505-14. doi: 10.1081/jcmr-120022267.'}, {'pmid': '11197356', 'type': 'BACKGROUND', 'citation': 'Wu E, Judd RM, Vargas JD, Klocke FJ, Bonow RO, Kim RJ. Visualisation of presence, location, and transmural extent of healed Q-wave and non-Q-wave myocardial infarction. Lancet. 2001 Jan 6;357(9249):21-8. doi: 10.1016/S0140-6736(00)03567-4.'}, {'pmid': '12505229', 'type': 'BACKGROUND', 'citation': 'Choudhury L, Mahrholdt H, Wagner A, Choi KM, Elliott MD, Klocke FJ, Bonow RO, Judd RM, Kim RJ. Myocardial scarring in asymptomatic or mildly symptomatic patients with hypertrophic cardiomyopathy. J Am Coll Cardiol. 2002 Dec 18;40(12):2156-64. doi: 10.1016/s0735-1097(02)02602-5.'}, {'pmid': '12821550', 'type': 'BACKGROUND', 'citation': 'McCrohon JA, Moon JC, Prasad SK, McKenna WJ, Lorenz CH, Coats AJ, Pennell DJ. Differentiation of heart failure related to dilated cardiomyopathy and coronary artery disease using gadolinium-enhanced cardiovascular magnetic resonance. Circulation. 2003 Jul 8;108(1):54-9. doi: 10.1161/01.CIR.0000078641.19365.4C. Epub 2003 Jun 23.'}, {'pmid': '12570960', 'type': 'BACKGROUND', 'citation': "Gibbons RJ, Abrams J, Chatterjee K, Daley J, Deedwania PC, Douglas JS, Ferguson TB Jr, Fihn SD, Fraker TD Jr, Gardin JM, O'Rourke RA, Pasternak RC, Williams SV; American College of Cardiology; American Heart Association Task Force on practice guidelines (Committee on the Management of Patients With Chronic Stable Angina). ACC/AHA 2002 guideline update for the management of patients with chronic stable angina--summary article: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines (Committee on the Management of Patients With Chronic Stable Angina). J Am Coll Cardiol. 2003 Jan 1;41(1):159-68. doi: 10.1016/s0735-1097(02)02848-6. No abstract available."}, {'pmid': '9456215', 'type': 'BACKGROUND', 'citation': 'Metz CE, Herman BA, Roe CA. Statistical comparison of two ROC-curve estimates obtained from partially-paired datasets. Med Decis Making. 1998 Jan-Mar;18(1):110-21. doi: 10.1177/0272989X9801800118.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate the feasibility and diagnostic performance of a novel rapid regadenoson stress CMR protocol for detecting of obstructive coronary artery disease.', 'detailedDescription': 'This is a single center, open-label, pilot study in subjects scheduled for invasive coronary angiography for evaluation of coronary artery disease. The primary objective is to evaluate the profile of sensitivity, specificity, and diagnostic accuracy of a novel rapid regadenoson stress CMR protocol for detection of \\>= 70 coronary artery stenosis on invasive coronary angiography. Additionally the objective will be to compare the time for performance of this novel rapid regadenoson stress CMR protocol in comparison to the standard stress CMR protocol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18 years or older\n* Scheduled for invasive coronary angiography\n\nExclusion Criteria:\n\n* Inability to give informed consent\n* Possible pregnancy (confirmed by urine test)\n* Women who are breastfeeding\n* Severe claustrophobia\n* Inability to lie flat for 20-30 minutes (the anticipated amount of time to complete the MRI procedure)\n* Individuals with cochlear implants\n* Individuals with non-MRI compatible aneurysm clips\n* Potential contraindications to regadenoson use due to:\n\nSevere lung disease (active wheezing) Severe bradycardia (heart rate \\< 40 beats/min) Second- or third-degree atrioventricular heart block Sick sinus syndrome History of Long QT syndrome Severe hypotension (systolic BP \\< 80 mm Hg) Decompensated heart failure\n\n* Contraindication to administration of Gadolinium (Gd) based contrast agents (GBCA):\n\nStage 4 or 5 chronic kidney disease (eGFR \\< 30 ml/min/1.73 m2) Known allergy to GBCA\n\nSpecial Considerations:\n\n\\- Although individuals who have an occupational history of welding, grinding, or other metal work will not be excluded from the study, they must undergo an orbital x-ray, to exclude any occult metal fragments, before they can participate in this study.'}, 'identificationModule': {'nctId': 'NCT01446094', 'briefTitle': 'Diagnostic Study of Rapid Regadenoson Stress Cardiovascular Magnetic Resonance (CMR) to Detect Coronary Artery Disease', 'organization': {'class': 'OTHER', 'fullName': 'The Methodist Hospital Research Institute'}, 'officialTitle': 'Diagnostic Value of a Rapid Protocol Regadenoson Stress Cardiovascular Magnetic Resonance Scan for Detection of Coronary Artery Disease', 'orgStudyIdInfo': {'id': 'Pro00006077'}, 'secondaryIdInfos': [{'id': 'IRB(2)0511-0092', 'type': 'OTHER', 'domain': 'HMRI IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'single-arm', 'description': 'Additional images collected during routine cardiac MRI (CMR) with diagnostic imaging agent, regadenoson.', 'interventionNames': ['Drug: regadenoson']}], 'interventions': [{'name': 'regadenoson', 'type': 'DRUG', 'otherNames': ['Lexiscan'], 'description': 'Intravenous administration of 0.4 mg dose of Regadenoson using per routine CMR, as indicated in the package insert.', 'armGroupLabels': ['single-arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ghosn Mohamad, PhD', 'role': 'CONTACT', 'email': 'mghosn@houstonmethodist.org', 'phone': '713-441-9837'}, {'name': 'Dipan J Shah, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Neal S Kleiman, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Faisal Nabi, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Kamran Shaikh, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'The Methodist Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Mohaman Ghosn, PhD', 'role': 'CONTACT', 'email': 'mghosn@houstonmethodist.org', 'phone': '713-441-9837'}], 'overallOfficials': [{'name': 'Dipan Shah, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Methodist Hospital Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Plan to share data to be determined.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dipan Shah', 'class': 'OTHER'}, 'collaborators': [{'name': 'Astellas Pharma Global Development, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director, Cardiac Magnetic Resonance Imaging', 'investigatorFullName': 'Dipan Shah', 'investigatorAffiliation': 'The Methodist Hospital Research Institute'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2019-01-31', 'type': 'RELEASE'}, {'date': '2019-02-21', 'type': 'RESET'}, {'date': '2019-09-27', 'type': 'RELEASE'}, {'date': '2019-10-16', 'type': 'RESET'}, {'date': '2021-11-17', 'type': 'RELEASE'}, {'date': '2021-12-15', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Dipan Shah, Director, Cardiac Magnetic Resonance Imaging, The Methodist Hospital Research Institute'}}}}