An interventional study of Cardiac magnetic resonance imaging (CMR) in Cardiomyopathy, sponsored by Ottawa Hospital Research Institute. Completed at 1 site in Canada. Per ClinicalTrials.gov, last updated 2020-08-24.
Sponsored by Ottawa Hospital Research Institute · Not applicable, Interventional, and Other
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.
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.
1,176 studies on the registry are indexed under Cardiomyopathies; 287 are open to participants now.
This study's enrollment of 35 is below the median of 51 across 609 interventional studies indexed under Cardiomyopathies.
Browse Cardiomyopathies studies →Ottawa Hospital Research Institute is the lead sponsor of 538 studies on the registry; 100 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients who received either right or left total hip resurfacing procedure. This group of patients will undergo a cardiac magnetic resonance imaging (CMR).
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).
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).
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.
Cardiac Ejection Fraction
The volumetric fraction of fluid ejected from a chamber with each contraction.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: One time measure at CMR
Cobalt and Chromium Ion Levels
To measure the level of cobalt and chromium ions in blood
Time frame: Immediately Prior to cardiac MRI
| Milestone | Unilateral Hip Resurfacing | Bilateral Hip Resurfacing | Non-Metal on Metal Total Hip |
|---|---|---|---|
| Started | 12 | 12 | 11 |
| Completed | 10 | 10 | 10 |
| Not completed | 2 | 2 | 1 |
| Withdrew: Screening failure | 2 | 2 | 1 |
The volumetric fraction of fluid ejected from a chamber with each contraction.
| Percent | Unilateral Hip Resurfacing | Bilateral Hip Resurfacing | Non-Metal on Metal Total Hip |
|---|---|---|---|
| Left ventricular ejection fraction | 64 (60 to 69) | 66 (63 to 72) | 65 (59 to 70) |
| Right ventricular ejecton fraction | 62 (60 to 64) | 63 (58 to 70) | 62 (60 to 64) |
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
| mL/m^2 | Unilateral Hip Resurfacing | Bilateral Hip Resurfacing | Non-Metal on Metal Total Hip |
|---|---|---|---|
| Left ventricle end-diastolic volume (LVEDV) | 77 (68 to 80) | 73 (65 to 85) | 67 (61 to 70) |
| Left ventricle end-systolic volume (LVESV) | 27 (20 to 39) | 26 (23 to 29) | 23 (19 to 29) |
| Left ventricle stroke volume (LVSV) | 51 (42 to 56) | 46 (41 to 62) | 43 (41 to 46) |
| Right ventricle end-diastolic volume (RVEDV) | 79 (76 to 87) | 82 (76 to 84) | 71 (64 to 77) |
| Right ventricle end-systolic volume (RVESV) | 30 (22 to 35) | 30 (24 to 31) | 28 (22 to 31) |
| Right ventricle stroke volume (RVSV) | 53 (46 to 57) | 50 (41 to 56) | 43 (41 to 46) |
T2\* is a specific sequence in the cardiac MRI and mapping can lead to important indicators of cardiac structure and function.
| ms | Unilateral Hip Resurfacing | Bilateral Hip Resurfacing | Non-Metal on Metal Total Hip |
|---|---|---|---|
| Myocardium | 32 (32 to 34) | 33 (32 to 34) | 33 (30 to 37) |
| Liver | 27 (23 to 29) | 24 (15 to 26) | 28 (27 to 30) |
T1 is a specific sequence in the cardiac MRI and mapping can lead to important indicators of cardiac structure and function.
| ms | Unilateral Hip Resurfacing | Bilateral Hip Resurfacing | Non-Metal on Metal Total Hip |
|---|---|---|---|
| Native T1 left ventricle (LV) average | 1003 (988 to 1014) | 988 (980 to 997) | 993 (987 to 1007) |
| Post gadolinium T1 left ventricle (LV) average | 402 (384 to 432) | 409 (402 to 418) | 383 (371 to 397) |
To measure the level of cobalt and chromium ions in blood
| ug/L | Unilateral Hip Resurfacing | Bilateral Hip Resurfacing | Non-Metal on Metal Total Hip |
|---|---|---|---|
| Chromium blood levels | 1.41 (0.97 to 2.00) | 2.58 (1.60 to 2.90) | 0.11 (0.10 to 1.80) |
| Cobat blood levels | 0.71 (0.50 to 1.07) | 1.47 (1.33 to 2.16) | 0.18 (0.16 to 0.19) |
Collected over 90 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Unilateral Hip Resurfacing | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Bilateral Hip Resurfacing | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Non-Metal on Metal Total Hip | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Age, Continuous(years) | Unilateral Hip Resurfacing | Bilateral Hip Resurfacing | Non-Metal on Metal Total Hip | Total |
|---|---|---|---|---|
| Mean | 59.4 (52.2 to 66.5) | 57.7 (48.5 to 70.1) | 58.4 (51.8 to 70.2) | 58.5 (48.5 to 70.2) |
| Sex: Female, Male(Participants) | Unilateral Hip Resurfacing | Bilateral Hip Resurfacing | Non-Metal on Metal Total Hip | Total |
|---|---|---|---|---|
| Female | 1 | 2 | 4 | 7 |
| Male | 9 | 8 | 6 | 23 |
| Race and Ethnicity Not Collected(Participants) | Unilateral Hip Resurfacing | Bilateral Hip Resurfacing | Non-Metal on Metal Total Hip | Total |
|---|---|---|---|---|
| Count of participants | — | — | — | 0 |
| Time since implantation(years) | Unilateral Hip Resurfacing | Bilateral Hip Resurfacing | Non-Metal on Metal Total Hip | Total |
|---|---|---|---|---|
| Mean | 9.1 (5.9 to 11.1) | 7.5 (6.7 to 9.1) | 6.7 (5.0 to 10.6) | 7.8 (5.0 to 11.1) |
| Body Mass Index (BMI)(kg/m^2) | Unilateral Hip Resurfacing | Bilateral Hip Resurfacing | Non-Metal on Metal Total Hip | Total |
|---|---|---|---|---|
| Mean | 28.1 (25.1 to 31.1) | 29.0 (25.3 to 34.4) | 27.1 (22.5 to 32.5) | 28.1 (22.5 to 34.4) |
| Body Surface Area (BSA)(m^2) | Unilateral Hip Resurfacing | Bilateral Hip Resurfacing | Non-Metal on Metal Total Hip | Total |
|---|---|---|---|---|
| Mean | 2.04 (1.93 to 2.23) | 2.08 (1.79 to 2.32) | 1.97 (1.69 to 2.45) | 2.03 (1.69 to 2.45) |
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Ottawa Hospital Research Institute