Diagnostic Study of Rapid Regadenoson Stress Cardiovascular Magnetic Resonance (CMR) to Detect Coronary Artery Disease
NCT ID: NCT01446094
Last Updated: 2017-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
50 participants
INTERVENTIONAL
2011-08-31
2018-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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single-arm
Additional images collected during routine cardiac MRI (CMR) with diagnostic imaging agent, regadenoson.
regadenoson
Intravenous administration of 0.4 mg dose of Regadenoson using per routine CMR, as indicated in the package insert.
Interventions
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regadenoson
Intravenous administration of 0.4 mg dose of Regadenoson using per routine CMR, as indicated in the package insert.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Scheduled for invasive coronary angiography
Exclusion Criteria
* Possible pregnancy (confirmed by urine test)
* Women who are breastfeeding
* Severe claustrophobia
* Inability to lie flat for 20-30 minutes (the anticipated amount of time to complete the MRI procedure)
* Individuals with cochlear implants
* Individuals with non-MRI compatible aneurysm clips
* Potential contraindications to regadenoson use due to:
Severe 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
* Contraindication to administration of Gadolinium (Gd) based contrast agents (GBCA):
Stage 4 or 5 chronic kidney disease (eGFR \< 30 ml/min/1.73 m2) Known allergy to GBCA
Special Considerations:
\- 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.
18 Years
ALL
No
Sponsors
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Astellas Pharma Global Development, Inc.
INDUSTRY
Dipan Shah
OTHER
Responsible Party
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Dipan Shah
Director, Cardiac Magnetic Resonance Imaging
Principal Investigators
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Dipan Shah, M.D.
Role: PRINCIPAL_INVESTIGATOR
The Methodist Hospital Research Institute
Locations
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The Methodist Hospital
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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IRB(2)0511-0092
Identifier Type: OTHER
Identifier Source: secondary_id
Pro00006077
Identifier Type: -
Identifier Source: org_study_id