Cardiomyopathy, DilatedNCT00549861
Characterization of Irreversible Myocardial Injury in Cardiomyopathies by Contrast-enhanced CMR
A study testing Cardiac Magnetic Resonance study in people with Cardiomyopathy, Dilated and Cardiomyopathies, Secondary, run by Oliver Strohm at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiomyopathy, Dilated, Cardiomyopathies, Secondary
- What is being tested?
- Cardiac Magnetic Resonance study
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2007to Aug 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Known cardiomyopathy (DCM, HCM, ARVC or LVNC)
- Clinical indication for contrast-enhanced Cardiac Magnetic Resonance study
- Ability to give informed consent
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Stephenson CMR Centre at Foothills Medical Centre, University of Calgary
Calgary, Alberta, T2N 2T9
About this study
Official title: 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.
Read the 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.
- Being tested
- Cardiac Magnetic Resonance study
- Keywords
- Cardiac Magnetic Resonance Imaging, Contrast agents, Gadobutrol, Fibrosis, Prognosis, Magnetic Resonance, Gadolinium
- Medical subject headings
- Cardiomyopathy, Dilated, Cardiomyopathies, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Magnetic Resonance studyProcedure or surgery
Cardiac MRI study
| Study group | Role | What they receive |
|---|---|---|
| A1 | No intervention | CMR study for the assessment of irreversible tissue damage Receives: Procedure: Cardiac Magnetic Resonance study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extent and spatial distribution of irreversible tissue injury within the group of dilated forms of cardiomyopathies
Measured: 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.
Measured: within one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2007 (estimated)
- Study startSep 2007
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cardiomyopathy, DilatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oliver Strohm
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor-investigator, Oliver Strohm, University of Calgary
- Investigators
- Oliver Strohm, MD, FESC, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00549861
- Sponsor's protocol ID
- Gadovist001
- Status last verified
- Oct 2011
- First submitted
- 24 Oct 2007
- Last updated
- 4 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 15936612Jassal 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.
PubMed 16755837Maceira 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.
PubMed 15630027Smedema 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.
PubMed 15893188Assomull 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.
PubMed 17112987Tandri 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.
PubMed 15629382Moon 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.
PubMed 12742298
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Irreversible Myocardial Injury in Dilated Forms of Cardiomyopathies by Gadobutrol (Gadovist®)-Enhanced Cardiovascular Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT00549861
- Acronym / sponsor ID
- Gadovist001
- Keywords
- Cardiac Magnetic Resonance Imaging, Contrast agents, Gadobutrol, Fibrosis, Prognosis, Magnetic Resonance, Gadolinium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Oliver StrohmUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Sep 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 26 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A1 | No intervention | Procedure: Cardiac Magnetic Resonance studyCMR study for the assessment of irreversible tissue damage |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Known cardiomyopathy (DCM, HCM, ARVC or LVNC)
- Clinical indication for contrast-enhanced Cardiac Magnetic Resonance study
- Ability to give informed consent
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac Magnetic Resonance studyCardiac MRI study | Procedure or surgery | A1 |
Primary outcome
Extent and spatial distribution of irreversible tissue injury within the group of dilated forms of cardiomyopathies
Time frame: within one year
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2011.
- Background: PubMed 15936612Abdel-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.
- Background: PubMed 16755837Jassal 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.
- Background: PubMed 15630027Maceira 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.
- Background: PubMed 15893188Smedema 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.
- Background: PubMed 17112987Assomull 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.
- Background: PubMed 15629382Tandri 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.
- Background: PubMed 12742298Moon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oliver Strohm, MD, FESC principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac Magnetic Resonance study in people with Cardiomyopathy, Dilated and Cardiomyopathies, Secondary, run by Oliver Strohm at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extent and spatial distribution of irreversible tissue injury within the group of dilated forms of cardiomyopathies (time frame: within one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00549861, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2011.