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

October 2, 2011 updated by: Oliver Strohm

Characterization of Irreversible Myocardial Injury in Dilated Forms of Cardiomyopathies by Gadobutrol (Gadovist®)-Enhanced Cardiovascular Magnetic Resonance Imaging

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Stephenson CMR Centre at Foothills Medical Centre, University of Calgary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: A1
CMR study for the assessment of irreversible tissue damage
Procedure: Cardiac Magnetic Resonance study
Cardiac MRI study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Extent and spatial distribution of irreversible tissue injury within the group of dilated forms of cardiomyopathies
Time Frame: within one year
within one year

Secondary Outcome Measures

Outcome Measure
Time Frame
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
within one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oliver Strohm

Collaborators

Bayer

Investigators

  • Principal Investigator: Oliver Strohm, MD, FESC, University of Calgary

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

October 24, 2007

First Submitted That Met QC Criteria

October 25, 2007

First Posted (Estimate)

October 26, 2007

Study Record Updates

Last Update Posted (Estimate)

October 4, 2011

Last Update Submitted That Met QC Criteria

October 2, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Gadovist001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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