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

Sponsor
Oliver Strohm (Other)
Overall Status
Completed
CT.gov ID
NCT00549861
Collaborator
Bayer (Industry)
40
1
1
11
3.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Cardiac Magnetic Resonance study
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (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
Study Start Date :
Sep 1, 2007
Actual Primary Completion Date :
Aug 1, 2008
Actual Study Completion Date :
Aug 1, 2008

Arms and Interventions

Arm Intervention/Treatment
No Intervention: A1

CMR study for the assessment of irreversible tissue damage

Procedure: Cardiac Magnetic Resonance study
Cardiac MRI study

Outcome Measures

Primary Outcome Measures

  1. Extent and spatial distribution of irreversible tissue injury within the group of dilated forms of cardiomyopathies [within one year]

Secondary Outcome Measures

  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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Oliver Strohm, Deputy Director, University of Calgary
ClinicalTrials.gov Identifier:
NCT00549861
Other Study ID Numbers:
  • Gadovist001
First Posted:
Oct 26, 2007
Last Update Posted:
Oct 4, 2011
Last Verified:
Oct 1, 2011
Keywords provided by Oliver Strohm, Deputy Director, University of Calgary
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 4, 2011