CardiomyopathyCardiacMRINCT02892448
Cardiac MRI for Metal on Metal Hip Resurfacing
A study testing Cardiac magnetic resonance imaging (CMR) in people with Cardiomyopathy, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
There may be a relationship between heart function and the metal ion levels in patients having undergone total hip replacement. The idea is to use results from a clinical cardiac MRI to assess heart function in a sample of 30 patients whom have undergone either metal-on-metal hip replacement (unilateral or bilateral)… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiomyopathy
- What is being tested?
- Cardiac magnetic resonance imaging (CMR)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2016to 20 Jul 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Undergoing clinical Cardiac MRI
- Currently enrolled with either unilateral or bilateral metal-on-metal (MoM) Hip replacement device
- Willing to sign Informed Consent Form
Who cannot join
- Patient does not meet all 'inclusion' criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiac MRI for Metal on Metal Orthopaedic Prostheses
There may be a relationship between heart function and the metal ion levels in patients having undergone total hip replacement. The idea is to use results from a clinical cardiac MRI to assess heart function in a sample of 30 patients whom have undergone either metal-on-metal hip replacement (unilateral or bilateral) or a non-metal on metal total hip replacement to determine whether having undergone a metal on metal hip procedure may be impacting heart function. In addition to the clinically used parameters, the images will also be retrospectively assessed using special software to assess amount of fibrosis and early changes affecting cardiac muscle contraction which may be indicative of impaired heart function. With these values we will compare to known, and previously collected, hip replacement and function data to determine whether there is any differences in how the heart works in those having had a hip replacement relative to a normal population.
Read the detailed description
There has been some recent concern regarding possible systemic health effects resulting from elevated blood cobalt concentrations in patients with cobalt containing hip implants (1). To date there are no blood cobalt criteria to help guide physicians when evaluating an individual hip implant patient's risk of developing systemic health effects because historically there was little or no concern about systemic cobalt toxicity in implant patients. Included within this is heart function, for which investigators see a need to use this novel software to analyze heart function relative to Hip status and Metal Ion levels.
Patients with metal on metal hip prosthesis are subject to local and systemic release of cobalt and chromium ions which may increase the potential for locally aggressive ion-induced local tissue reactions such as pseudotumours, a type of Adverse Reaction to Metal Debris (ARMD) (2). Although there have been reports of local toxicity as well as cases of cobaltism (as seen during outbreak in Quebec of so called 'cobalt beer drinkers' cardiomyopathy) leading to cardiac and ototoxicity, it is unclear if chronic exposure to these ions can lead to impaired cardiac function (cardiotoxicity) in a well-functioning prosthesis.
The majority of the blood cobalt concentrations reported for hip implant patients appear to range from approximately 0.2 to 10 µg/L, and based on our review of the available literature, should not pose an increased risk for the development of systemic health effects.
The concern for systemic health effects is for the small number of patients with cobalt-containing hip implants with markedly elevated blood cobalt concentrations.
Extensive evaluations of these 'cobalt beer drinkers' have found that poor nutrition and underlying disease states caused by severe alcoholism were likely significant contributing factors to heart disease in this particular population. However, there remains a significant concern that cardiac function could be affected in the long term. This is especially relevant as the majority of these implants are put in patients less than 50 years age.
Cardiac magnetic resonance imaging (CMR) is the gold standard method to assess cardiac function in patients at risk of cardiotoxicity. In addition to assessing cardiac function, CMR enables imaging of inflammation, and fibrosis (which may be secondary to the ion deposition) in the heart which may provide more specific information about the mechanism of injury in these patients.
The purpose of this study is to look at cardiac function in patients with a metal on metal hip prostheses.
Recruitment: 30 patients in total (10 unilateral and 10 bilateral hip resurfacing patients and 10 non-metal on metal total hip replacement patients) will be recruited which should provide indication of relationship both between either instances and heart function, as well as compared to one another. All patients will be undergoing clinical cardiac MRI. All patients will have extra images collected during their MRI and these images will be analyzed to determine any relationship between heart function and the possible metal ion levels from the hip implant. As part of the scan analysis they will be required to also have a 5 millilitres (mLs) vial of blood collected. Ultrasound values will be retrospectively collected, for analysis of soft tissue reaction, from a previous clinically ordered ultrasound of the affected joint.
- Conditions
- Cardiomyopathy
- Being tested
- Cardiac magnetic resonance imaging (CMR)
- Medical subject headings
- Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac magnetic resonance imaging (CMR)Other
Cardiac MRI is used to assess cardiac function in patients at risk of cardiotoxicity. In addition, Cardiac MRI enables imaging of inflammation, and fibrosis in the heart which may provide more specific information about the mechanism of injury in patients with high ion blood levels. Patients in all three groups (Unilateral hip resurfacing, bilateral hip resurfacing, and non-metal on metal total hip arthroplasty) will undergo a Cardiac MRI.
| Study group | Role | What they receive |
|---|---|---|
| Unilateral Hip Resurfacing | Active comparator | Patients who received either right or left total hip resurfacing procedure. This group of patients will undergo a cardiac magnetic resonance imaging (CMR). Receives: Other: Cardiac magnetic resonance imaging (CMR) |
| Bilateral Hip Resurfacing | Active comparator | Patients who received both right and left hip resurfacing procedure on the same day. This group of patients will undergo a cardiac magnetic resonance imaging (CMR). Receives: Other: Cardiac magnetic resonance imaging (CMR) |
| Non-Metal on Metal Total Hip | Active comparator | Patients who received either a unilateral (one hip) or bilateral (both hips) non-metal on metal total hip arthroplasty. This group of patients will undergo a cardiac magnetic resonance imaging (CMR). Receives: Other: Cardiac magnetic resonance imaging (CMR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Ejection Fraction
The volumetric fraction of fluid ejected from a chamber with each contraction.
Measured: Minimum 5 years post-operative
Comprehensive Cardiac Function
Volume measures including: left ventricular end-diastolic volume, left ventricular stroke volume, right ventricular end-diastolic volume, right ventricular end-systolic volume, right ventricular stroke volume
Measured: One time measure at CMR
T2* Mapping Time
T2* is a specific sequence in the cardiac MRI and mapping can lead to important indicators of cardiac structure and function.
Measured: One time measure at CMR
T1 Mapping Time
T1 is a specific sequence in the cardiac MRI and mapping can lead to important indicators of cardiac structure and function.
Measured: One time measure at CMR
Secondary outcomes (1)
Cobalt and Chromium Ion Levels
To measure the level of cobalt and chromium ions in blood
Measured: Immediately Prior to cardiac MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study startSep 2016
- Primary completion20 Jul 2019
- Study completion20 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Ottawa Heart Institute Research Corporation
- Responsible party
- Sponsor
- Investigators
- Paul E Beaule, MD, FRCSC, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02892448
- Sponsor's protocol ID
- 20150281
- Acronym
- CardiacMRI
- Status last verified
- Jul 2020
- First submitted
- 4 Aug 2016
- Last updated
- 24 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim PR, Beaule PE, Dunbar M, Lee JK, Birkett N, Turner MC, Yenugadhati N, Armstrong V, Krewski D. Cobalt and chromium levels in blood and urine following hip resurfacing arthroplasty with the Conserve Plus implant. J Bone Joint Surg Am. 2011 May;93 Suppl 2:107-17. doi: 10.2106/JBJS.J.01721.
PubMed 21543699Moon JC, Messroghli DR, Kellman P, Piechnik SK, Robson MD, Ugander M, Gatehouse PD, Arai AE, Friedrich MG, Neubauer S, Schulz-Menger J, Schelbert EB; Society for Cardiovascular Magnetic Resonance Imaging; Cardiovascular Magnetic Resonance Working Group of the European Society of Cardiology. Myocardial T1 mapping and extracellular volume quantification: a Society for Cardiovascular Magnetic Resonance (SCMR) and CMR Working Group of the European Society of Cardiology consensus statement. J Cardiovasc Magn Reson. 2013 Oct 14;15(1):92. doi: 10.1186/1532-429X-15-92.
PubMed 24124732Messroghli DR, Greiser A, Frohlich M, Dietz R, Schulz-Menger J. Optimization and validation of a fully-integrated pulse sequence for modified look-locker inversion-recovery (MOLLI) T1 mapping of the heart. J Magn Reson Imaging. 2007 Oct;26(4):1081-6. doi: 10.1002/jmri.21119.
PubMed 17896383Diesbourg LD, Prato FS, Wisenberg G, Drost DJ, Marshall TP, Carroll SE, O'Neill B. Quantification of myocardial blood flow and extracellular volumes using a bolus injection of Gd-DTPA: kinetic modeling in canine ischemic disease. Magn Reson Med. 1992 Feb;23(2):239-53. doi: 10.1002/mrm.1910230205.
PubMed 1549039Juneau D, Grammatopoulos G, Alzahrani A, Thornhill R, Inacio JR, Dick A, Vogel KI, Dobransky J, Beaule PE, Dwivedi G. Is end-organ surveillance necessary in patients with well-functioning metal-on-metal hip resurfacings? A cardiac MRI survey. Bone Joint J. 2019 May;101-B(5):540-546. doi: 10.1302/0301-620X.101B5.BJJ-2018-1478.R1.
PubMed 31039002
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac MRI for Metal on Metal Orthopaedic Prostheses
- ClinicalTrials.gov ID
- NCT02892448
- Acronym / sponsor ID
- CardiacMRI / 20150281
- Conditions
- Cardiomyopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Ottawa Heart Institute Research Corporation
- Study start
- Sep 2016 (actual)
- Primary completion
- 20 Jul 2019 (actual)
- Study completion
- 20 Jul 2019 (actual)
- First posted
- 8 Sep 2016 (estimated)
- Results
- Posted 24 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There may be a relationship between heart function and the metal ion levels in patients having undergone total hip replacement. The idea is to use results from a clinical cardiac MRI to assess heart function in a sample of 30 patients whom have undergone either metal-on-metal hip replacement (unilateral or bilateral) or a non-metal on metal total hip replacement to determine whether having undergone a metal on metal hip procedure may be impacting heart function. In addition to the clinically used parameters, the images will also be retrospectively assessed using special software to assess amount of fibrosis and early changes affecting cardiac muscle contraction which may be indicative of impaired heart function. With these values we will compare to known, and previously collected, hip replacement and function data to determine whether there is any differences in how the heart works in those having had a hip replacement relative to a normal population.
Detailed description
There has been some recent concern regarding possible systemic health effects resulting from elevated blood cobalt concentrations in patients with cobalt containing hip implants (1). To date there are no blood cobalt criteria to help guide physicians when evaluating an individual hip implant patient's risk of developing systemic health effects because historically there was little or no concern about systemic cobalt toxicity in implant patients. Included within this is heart function, for which investigators see a need to use this novel software to analyze heart function relative to Hip status and Metal Ion levels.
Patients with metal on metal hip prosthesis are subject to local and systemic release of cobalt and chromium ions which may increase the potential for locally aggressive ion-induced local tissue reactions such as pseudotumours, a type of Adverse Reaction to Metal Debris (ARMD) (2). Although there have been reports of local toxicity as well as cases of cobaltism (as seen during outbreak in Quebec of so called 'cobalt beer drinkers' cardiomyopathy) leading to cardiac and ototoxicity, it is unclear if chronic exposure to these ions can lead to impaired cardiac function (cardiotoxicity) in a well-functioning prosthesis.
The majority of the blood cobalt concentrations reported for hip implant patients appear to range from approximately 0.2 to 10 µg/L, and based on our review of the available literature, should not pose an increased risk for the development of systemic health effects.
The concern for systemic health effects is for the small number of patients with cobalt-containing hip implants with markedly elevated blood cobalt concentrations.
Extensive evaluations of these 'cobalt beer drinkers' have found that poor nutrition and underlying disease states caused by severe alcoholism were likely significant contributing factors to heart disease in this particular population. However, there remains a significant concern that cardiac function could be affected in the long term. This is especially relevant as the majority of these implants are put in patients less than 50 years age.
Cardiac magnetic resonance imaging (CMR) is the gold standard method to assess cardiac function in patients at risk of cardiotoxicity. In addition to assessing cardiac function, CMR enables imaging of inflammation, and fibrosis (which may be secondary to the ion deposition) in the heart which may provide more specific information about the mechanism of injury in these patients.
The purpose of this study is to look at cardiac function in patients with a metal on metal hip prostheses.
Recruitment: 30 patients in total (10 unilateral and 10 bilateral hip resurfacing patients and 10 non-metal on metal total hip replacement patients) will be recruited which should provide indication of relationship both between either instances and heart function, as well as compared to one another. All patients will be undergoing clinical cardiac MRI. All patients will have extra images collected during their MRI and these images will be analyzed to determine any relationship between heart function and the possible metal ion levels from the hip implant. As part of the scan analysis they will be required to also have a 5 millilitres (mLs) vial of blood collected. Ultrasound values will be retrospectively collected, for analysis of soft tissue reaction, from a previous clinically ordered ultrasound of the affected joint.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Unilateral Hip Resurfacing | Active comparator | Other: Cardiac magnetic resonance imaging (CMR)Patients who received either right or left total hip resurfacing procedure. This group of patients will undergo a cardiac magnetic resonance imaging (CMR). |
| Bilateral Hip Resurfacing | Active comparator | Other: Cardiac magnetic resonance imaging (CMR)Patients who received both right and left hip resurfacing procedure on the same day. This group of patients will undergo a cardiac magnetic resonance imaging (CMR). |
| Non-Metal on Metal Total Hip | Active comparator | Other: Cardiac magnetic resonance imaging (CMR)Patients who received either a unilateral (one hip) or bilateral (both hips) non-metal on metal total hip arthroplasty. This group of patients will undergo a cardiac magnetic resonance imaging (CMR). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Undergoing clinical Cardiac MRI
- Currently enrolled with either unilateral or bilateral metal-on-metal (MoM) Hip replacement device
- Willing to sign Informed Consent Form
Key exclusion criteria (1 listed)
- Patient does not meet all 'inclusion' criteria
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 imaging (CMR)Cardiac MRI is used to assess cardiac function in patients at risk of cardiotoxicity. In addition, Cardiac MRI enables imaging of inflammation, and fibrosis in the heart which may provide more specific information about the mechanism of injury in patients with high ion blood levels. Patients in all three groups (Unilateral hip resurfacing, bilateral hip resurfacing, and non-metal on metal total hip arthroplasty) will undergo a Cardiac MRI. | Other | Bilateral Hip Resurfacing, Non-Metal on Metal Total Hip, Unilateral Hip Resurfacing |
Primary outcome
Cardiac Ejection Fraction
Time frame: Minimum 5 years post-operative
The volumetric fraction of fluid ejected from a chamber with each contraction.
Comprehensive Cardiac Function
Time frame: One time measure at CMR
Volume measures including: left ventricular end-diastolic volume, left ventricular stroke volume, right ventricular end-diastolic volume, right ventricular end-systolic volume, right ventricular stroke volume
T2* Mapping Time
Time frame: One time measure at CMR
T2* is a specific sequence in the cardiac MRI and mapping can lead to important indicators of cardiac structure and function.
T1 Mapping Time
Time frame: One time measure at CMR
T1 is a specific sequence in the cardiac MRI and mapping can lead to important indicators of cardiac structure and function.
1 secondary outcome
Cobalt and Chromium Ion Levels
Time frame: Immediately Prior to cardiac MRI
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21543699Kim PR, Beaule PE, Dunbar M, Lee JK, Birkett N, Turner MC, Yenugadhati N, Armstrong V, Krewski D. Cobalt and chromium levels in blood and urine following hip resurfacing arthroplasty with the Conserve Plus implant. J Bone Joint Surg Am. 2011 May;93 Suppl 2:107-17. doi: 10.2106/JBJS.J.01721.
- Background: PubMed 24124732Moon JC, Messroghli DR, Kellman P, Piechnik SK, Robson MD, Ugander M, Gatehouse PD, Arai AE, Friedrich MG, Neubauer S, Schulz-Menger J, Schelbert EB; Society for Cardiovascular Magnetic Resonance Imaging; Cardiovascular Magnetic Resonance Working Group of the European Society of Cardiology. Myocardial T1 mapping and extracellular volume quantification: a Society for Cardiovascular Magnetic Resonance (SCMR) and CMR Working Group of the European Society of Cardiology consensus statement. J Cardiovasc Magn Reson. 2013 Oct 14;15(1):92. doi: 10.1186/1532-429X-15-92.
- Background: PubMed 17896383Messroghli DR, Greiser A, Frohlich M, Dietz R, Schulz-Menger J. Optimization and validation of a fully-integrated pulse sequence for modified look-locker inversion-recovery (MOLLI) T1 mapping of the heart. J Magn Reson Imaging. 2007 Oct;26(4):1081-6. doi: 10.1002/jmri.21119.
- Background: PubMed 1549039Diesbourg LD, Prato FS, Wisenberg G, Drost DJ, Marshall TP, Carroll SE, O'Neill B. Quantification of myocardial blood flow and extracellular volumes using a bolus injection of Gd-DTPA: kinetic modeling in canine ischemic disease. Magn Reson Med. 1992 Feb;23(2):239-53. doi: 10.1002/mrm.1910230205.
- Results publication: PubMed 31039002Juneau D, Grammatopoulos G, Alzahrani A, Thornhill R, Inacio JR, Dick A, Vogel KI, Dobransky J, Beaule PE, Dwivedi G. Is end-organ surveillance necessary in patients with well-functioning metal-on-metal hip resurfacings? A cardiac MRI survey. Bone Joint J. 2019 May;101-B(5):540-546. doi: 10.1302/0301-620X.101B5.BJJ-2018-1478.R1.
- Individual participant dataSharing planned: No
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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.
Paul E Beaule, MD, FRCSC principal investigator
Ottawa Hospital Research Institute
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 imaging (CMR) in people with Cardiomyopathy, run by Ottawa Hospital Research Institute 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 1 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 24 Aug 2020. 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?
Yes. Results are posted in the registry (first posted 24 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cardiac Ejection Fraction (time frame: Minimum 5 years post-operative). The study lists 4 primary outcomes in all. 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 NCT02892448, which also lists 5 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 24 Aug 2020.