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Characterization of Irreversible Myocardial Injury in Cardiomyopathies by Contrast-enhanced CMR

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Oliver Strohm, University of Calgary
ClinicalTrials.gov Identifier:
NCT00549861
First received: October 24, 2007
Last updated: October 2, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention
Cardiomyopathy, Dilated
Cardiomyopathies, Secondary
Procedure: Cardiac Magnetic Resonance study

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Characterization of Irreversible Myocardial Injury in Dilated Forms of Cardiomyopathies by Gadobutrol (Gadovist®)-Enhanced Cardiovascular Magnetic Resonance Imaging

Resource links provided by NLM:


Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • Extent and spatial distribution of irreversible tissue injury within the group of dilated forms of cardiomyopathies [ Time Frame: within one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: within one year ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: September 2007
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: A1
CMR study for the assessment of irreversible tissue damage
Procedure: Cardiac Magnetic Resonance study
Cardiac MRI study

Detailed Description:

Dilated forms of cardiomyopathies present with left ventricular enlargement and reduced ejection fraction. Myocardial fibrosis as assessed by gradient echo sequences after contrast application ("late enhancement") has been proven to be of outstanding value for the detection of small irreversibly injured lesions and has been used to accurately characterize scarred tissue in infarcts (Kim et al, Circulation 1999), myocarditis (Mahrholdt et al., Circulation 2004), and hypertrophic cardiomyopathy (Moon et al., J Am Coll Cardiol 2004). Whereas fibrosis pattern have been described for non-ischemic cardiomyopathies (Mahrholdt et al., Eur Heart J 2005), little is known about the specific regional distribution of fibrous tissue within the group of dilated forms. McCrohon et al. have described a mid-mural and a patchy pattern in patients with global LV dysfunction and no evidence of relevant coronary artery disease (McCrohon et al., Circulation 2003). This study however, did not include right ventricular cardiomyopathy patients and patients with isolated non-compaction as two important dilated forms of cardiomyopathy.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  • Any exclusion criteria for the administration of Gadovist® as stated in the product monograph for Warning and Precautions, e.g. Hx of allergic dispositions, or bronchial asthma; sickle cell anemia or hemoglobinopathies; renal insufficiency, with hypokalemia; convulsive states
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00549861

Locations
Canada, Alberta
Stephenson CMR Centre at Foothills Medical Centre, University of Calgary
Calgary, Alberta, Canada, T2N 2T9
Sponsors and Collaborators
Oliver Strohm
Bayer
Investigators
Principal Investigator: Oliver Strohm, MD, FESC University of Calgary
  More Information

Publications:

Responsible Party: Oliver Strohm, Deputy Director, University of Calgary
ClinicalTrials.gov Identifier: NCT00549861     History of Changes
Other Study ID Numbers: Gadovist001
Study First Received: October 24, 2007
Last Updated: October 2, 2011
Health Authority: Canada: Health Canada

Keywords provided by University of Calgary:
Cardiac Magnetic Resonance Imaging
Contrast agents
Gadobutrol
Fibrosis
Prognosis
Magnetic Resonance
Gadolinium

Additional relevant MeSH terms:
Cardiomyopathies
Cardiomyopathy, Dilated
Cardiomegaly
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 23, 2014