Characterization of Irreversible Myocardial Injury in Cardiomyopathies by Contrast-enhanced CMR
NCT ID: NCT00549861
Last Updated: 2011-10-04
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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COMPLETED
NA
40 participants
INTERVENTIONAL
2007-09-30
2008-08-31
Brief Summary
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In this study, we will apply dedicated T1- and T2-weighted CMR sequences before and after administration of Gadolinium-based contrast (Gadobutrol, Gadovist(r)), the study parameters will be full cardiac function, areas of edema, areas of inflammation and areas of fibrosis.
We hypothesize, that we can detect fibrotic areas in the myocardium using Gadobutrol (Gadovist (r)) better than with the commonly used Gadolinium-DTPA contrast agents. We also hypothesize, that fibrosis of the myocardium is correlated to prognosis of the patients.
Detailed Description
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Justification/relevance/purpose
The presence of fibrosis in dilated forms of cardiomyopathy may be predictive of progression of left ventricular dysfunction over time, as it may represent irreversible damage.
Gadobutrol will be used as the only contrast agent in this study; the significantly higher relaxivity as compared to other contrast agents will potentially allow the visualization of small, focal areas of irreversible injury in the myocardium, thus increasing sensitivity of the method to identify even localized fibrotic areas.
Objective, hypothesis
We attempt to define disease-specific patterns of extent and spatial distribution of irreversible tissue injury within the group of dilated forms of cardiomyopathies.
We hypothesize that in patients with dilated cardiomyopathies certain patterns of late enhancement can be identified, which are useful for a more specific phenotyping.
We also hypothesize that the use of Gadobutrol (Gadovist®) as the only contrast agent identifies small areas of irreversible tissue injury better than standard contrast agents and may be beneficial for diagnosing small fibrotic changes.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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A1
CMR study for the assessment of irreversible tissue damage
Cardiac Magnetic Resonance study
Cardiac MRI study
Interventions
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Cardiac Magnetic Resonance study
Cardiac MRI study
Eligibility Criteria
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Inclusion Criteria
* Clinical indication for contrast-enhanced Cardiac Magnetic Resonance study
* Ability to give informed consent
Exclusion Criteria
* Allergic reaction to Gadolinium-based contrast agents
* Known adverse reaction to Gadovist®
* Inability to give informed consent
* Known long-QT syndrome or other known conduction abnormalities
* Pregnancy or breast-feeding
* Conditions and concomitant medication which may prolong the QTc interval, e.g. long-QT syndrome, patients with hypokalemia, receiving Class I1 (e.g. quinidine, procainamide) or class III (amiodarone, sotalol) known antiarrhythmogenic drugs, or other medication that are known to prolong QT interval (such as cisapride, erythromycin, antipsychotic and antidepressants) - since there is a lack of clinical experience and potential risks with the concomitant use of these medication with the MRI contrast
* Patients with severe renal impairment (GFR \<30mL/min)
* Patients with previous reaction to MRI and / or CT contrast media
* Patients with acute renal dysfunction due to hepato-renal syndrome or patients in the perioperative liver transplantation period
* Patients with end-stage renal disease (GFR \<15mL/min/1.73m2)
* Unstable patients, e.g. from CCU / ICU
ALL
No
Sponsors
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Bayer
INDUSTRY
Oliver Strohm
OTHER
Responsible Party
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Oliver Strohm
Deputy Director
Principal Investigators
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Oliver Strohm, MD, FESC
Role: PRINCIPAL_INVESTIGATOR
University of Calgary
Locations
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Stephenson CMR Centre at Foothills Medical Centre, University of Calgary
Calgary, Alberta, Canada
Countries
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References
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Abdel-Aty H, Boye P, Zagrosek A, Wassmuth R, Kumar A, Messroghli D, Bock P, Dietz R, Friedrich MG, Schulz-Menger J. Diagnostic performance of cardiovascular magnetic resonance in patients with suspected acute myocarditis: comparison of different approaches. J Am Coll Cardiol. 2005 Jun 7;45(11):1815-22. doi: 10.1016/j.jacc.2004.11.069.
Jassal DS, Nomura CH, Neilan TG, Holmvang G, Fatima U, Januzzi J, Brady TJ, Cury RC. Delayed enhancement cardiac MR imaging in noncompaction of left ventricular myocardium. J Cardiovasc Magn Reson. 2006;8(3):489-91. doi: 10.1080/10976640600599502.
Maceira AM, Joshi J, Prasad SK, Moon JC, Perugini E, Harding I, Sheppard MN, Poole-Wilson PA, Hawkins PN, Pennell DJ. Cardiovascular magnetic resonance in cardiac amyloidosis. Circulation. 2005 Jan 18;111(2):186-93. doi: 10.1161/01.CIR.0000152819.97857.9D. Epub 2005 Jan 3.
Smedema JP, Snoep G, van Kroonenburgh MP, van Geuns RJ, Dassen WR, Gorgels AP, Crijns HJ. Evaluation of the accuracy of gadolinium-enhanced cardiovascular magnetic resonance in the diagnosis of cardiac sarcoidosis. J Am Coll Cardiol. 2005 May 17;45(10):1683-90. doi: 10.1016/j.jacc.2005.01.047. Epub 2005 Apr 25.
Assomull RG, Prasad SK, Lyne J, Smith G, Burman ED, Khan M, Sheppard MN, Poole-Wilson PA, Pennell DJ. Cardiovascular magnetic resonance, fibrosis, and prognosis in dilated cardiomyopathy. J Am Coll Cardiol. 2006 Nov 21;48(10):1977-85. doi: 10.1016/j.jacc.2006.07.049. Epub 2006 Oct 31.
Tandri H, Saranathan M, Rodriguez ER, Martinez C, Bomma C, Nasir K, Rosen B, Lima JA, Calkins H, Bluemke DA. Noninvasive detection of myocardial fibrosis in arrhythmogenic right ventricular cardiomyopathy using delayed-enhancement magnetic resonance imaging. J Am Coll Cardiol. 2005 Jan 4;45(1):98-103. doi: 10.1016/j.jacc.2004.09.053.
Moon JC, McKenna WJ, McCrohon JA, Elliott PM, Smith GC, Pennell DJ. Toward clinical risk assessment in hypertrophic cardiomyopathy with gadolinium cardiovascular magnetic resonance. J Am Coll Cardiol. 2003 May 7;41(9):1561-7. doi: 10.1016/s0735-1097(03)00189-x.
Other Identifiers
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Gadovist001
Identifier Type: -
Identifier Source: org_study_id