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Cardiac MRI for Metal on Metal Hip Resurfacing (CardiacMRI)

Primary Purpose

Cardiomyopathy

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cardiac magnetic resonance imaging (CMR)
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cardiomyopathy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Undergoing clinical Cardiac MRI
  • Currently enrolled with either unilateral or bilateral metal-on-metal (MoM) Hip replacement device
  • Willing to sign Informed Consent Form

Exclusion Criteria:

  • Patient does not meet all 'inclusion' criteria

Sites / Locations

  • Paul E Beaule

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Unilateral Hip Resurfacing

Bilateral Hip Resurfacing

Non-Metal on Metal Total Hip

Arm Description

Patients who received either right or left total hip resurfacing procedure. This group of patients will undergo a 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).

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).

Outcomes

Primary Outcome Measures

Cardiac Ejection Fraction
The volumetric fraction of fluid ejected from a chamber with each contraction.
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
T2* Mapping Time
T2* is a specific sequence in the cardiac MRI and mapping can lead to important indicators of cardiac structure and function.
T1 Mapping Time
T1 is a specific sequence in the cardiac MRI and mapping can lead to important indicators of cardiac structure and function.

Secondary Outcome Measures

Cobalt and Chromium Ion Levels
To measure the level of cobalt and chromium ions in blood

Full Information

First Posted
August 4, 2016
Last Updated
July 28, 2020
Sponsor
Ottawa Hospital Research Institute
Collaborators
Ottawa Heart Institute Research Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02892448
Brief Title
Cardiac MRI for Metal on Metal Hip Resurfacing
Acronym
CardiacMRI
Official Title
Cardiac MRI for Metal on Metal Orthopaedic Prostheses
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
July 20, 2019 (Actual)
Study Completion Date
July 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute
Collaborators
Ottawa Heart Institute Research Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiomyopathy

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Unilateral Hip Resurfacing
Arm Type
Active Comparator
Arm Description
Patients who received either right or left total hip resurfacing procedure. This group of patients will undergo a cardiac magnetic resonance imaging (CMR).
Arm Title
Bilateral Hip Resurfacing
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Non-Metal on Metal Total Hip
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Cardiac magnetic resonance imaging (CMR)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cardiac Ejection Fraction
Description
The volumetric fraction of fluid ejected from a chamber with each contraction.
Time Frame
Minimum 5 years post-operative
Title
Comprehensive Cardiac Function
Description
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
Time Frame
One time measure at CMR
Title
T2* Mapping Time
Description
T2* is a specific sequence in the cardiac MRI and mapping can lead to important indicators of cardiac structure and function.
Time Frame
One time measure at CMR
Title
T1 Mapping Time
Description
T1 is a specific sequence in the cardiac MRI and mapping can lead to important indicators of cardiac structure and function.
Time Frame
One time measure at CMR
Secondary Outcome Measure Information:
Title
Cobalt and Chromium Ion Levels
Description
To measure the level of cobalt and chromium ions in blood
Time Frame
Immediately Prior to cardiac MRI

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Undergoing clinical Cardiac MRI Currently enrolled with either unilateral or bilateral metal-on-metal (MoM) Hip replacement device Willing to sign Informed Consent Form Exclusion Criteria: Patient does not meet all 'inclusion' criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul E Beaule, MD, FRCSC
Organizational Affiliation
The Ottawa Hospital Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Paul E Beaule
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H8L6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21543699
Citation
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.
Results Reference
background
PubMed Identifier
24124732
Citation
Moon 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.
Results Reference
background
PubMed Identifier
17896383
Citation
Messroghli 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.
Results Reference
background
PubMed Identifier
1549039
Citation
Diesbourg 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 Reference
background
PubMed Identifier
31039002
Citation
Juneau 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.
Results Reference
result

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Cardiac MRI for Metal on Metal Hip Resurfacing

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