NCT00549861

Brief Summary

Different studies have shown that fibrosis of the heart increases the risk for a sudden death from e.g. arrhythmias. Magnetic Resonance Imaging (CMR) can easily identify even small areas of fibrosis in the heart muscle after contrast agent application (Gadolinium). With the development of faster scanners and new contrast agents, the detection of small fibrotic areas may even be improved. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 26, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

October 4, 2011

Status Verified

October 1, 2011

Enrollment Period

11 months

First QC Date

October 24, 2007

Last Update Submit

October 2, 2011

Conditions

Cardiomyopathy, DilatedCardiomyopathies, Secondary

Keywords

Cardiac Magnetic Resonance ImagingContrast agentsGadobutrolFibrosisPrognosisMagnetic ResonanceGadolinium

Outcome Measures

Primary Outcomes (1)

  • Extent and spatial distribution of irreversible tissue injury within the group of dilated forms of cardiomyopathies

    within one year

Secondary Outcomes (1)

  • Use of Gadobutrol (Gadovist®) identifies small areas of irreversible tissue injury better than standard contrast agents and may be beneficial for diagnosing small fibrotic changes.

    within one year

Study Arms (1)

A1

NO INTERVENTION

CMR study for the assessment of irreversible tissue damage

Procedure: Cardiac Magnetic Resonance study

Interventions

Cardiac Magnetic Resonance studyPROCEDURE

Cardiac MRI study

A1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Known cardiomyopathy (DCM, HCM, ARVC or LVNC)
  • Clinical indication for contrast-enhanced Cardiac Magnetic Resonance study
  • Ability to give informed consent

You may not qualify if:

  • Any contraindication for a Magnetic Resonance Study including implanted devices, claustrophobia etc.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stephenson CMR Centre at Foothills Medical Centre, University of Calgary

Calgary, Alberta, T2N 2T9, Canada

Location

Related Publications (7)

  • 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.

    PMID: 15936612BACKGROUND

  • 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.

    PMID: 16755837BACKGROUND

  • 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.

    PMID: 15630027BACKGROUND

  • 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.

    PMID: 15893188BACKGROUND

  • 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.

    PMID: 17112987BACKGROUND

  • 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.

    PMID: 15629382BACKGROUND

  • 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.

    PMID: 12742298BACKGROUND

MeSH Terms

Conditions

Cardiomyopathy, DilatedCardiomyopathiesFibrosis

Condition Hierarchy (Ancestors)

CardiomegalyHeart DiseasesCardiovascular DiseasesLaminopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Oliver Strohm, MD, FESC

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Deputy Director

Study Record Dates

First Submitted

October 24, 2007

First Posted

October 26, 2007

Study Start

September 1, 2007

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

October 4, 2011

Record last verified: 2011-10

Locations

CA(1)