Cardiac MRI for Metal on Metal Hip Resurfacing

Cardiomyopathy Clinical Trial

— CardiacMRI  

Official title:

Cardiac MRI for Metal on Metal Orthopaedic Prostheses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02892448
• Other study ID #: 20150281
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: July 20, 2019

Study information

• Verified date: July 2020
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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) 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: July 20, 2019
• Est. primary completion date: July 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Canada	Paul E Beaule	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	Ottawa Heart Institute Research Corporation

Country where clinical trial is conducted

Canada, 

References & Publications (5)

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. — View Citation

Juneau D, Grammatopoulos G, Alzahrani A, Thornhill R, Inacio JR, Dick A, Vogel KI, Dobransky J, Beaulé 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 — View Citation

Kim PR, Beaulé 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. — View Citation

Messroghli DR, Greiser A, Fröhlich 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. — View 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;15:92. doi: 10.1186/1532-429X-15-92. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac Ejection Fraction	The volumetric fraction of fluid ejected from a chamber with each contraction.	Minimum 5 years post-operative
Primary	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	One time measure at CMR
Primary	T2* Mapping Time	T2* is a specific sequence in the cardiac MRI and mapping can lead to important indicators of cardiac structure and function.	One time measure at CMR
Primary	T1 Mapping Time	T1 is a specific sequence in the cardiac MRI and mapping can lead to important indicators of cardiac structure and function.	One time measure at CMR
Secondary	Cobalt and Chromium Ion Levels	To measure the level of cobalt and chromium ions in blood	Immediately Prior to cardiac MRI