N/A
N=35
Cardiac MRI for Metal on Metal Hip Resurfacing
Cardiomyopathy
Bottom Line
View on ClinicalTrials.gov: NCT02892448 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: Cardiac Ejection Fraction — 64; 66; 65; 62 Percent
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cardiac magnetic resonance imaging (CMR) (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Ottawa Hospital Research Institute
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cardiac Ejection Fraction |
64; 66; 65; 62; 63; 62 | — |
| PRIMARY Comprehensive Cardiac Function |
77; 73; 67; 27; 26; 23 | — |
| PRIMARY T2* Mapping Time |
32; 33; 33; 27; 24; 28 | — |
| PRIMARY T1 Mapping Time |
1003; 988; 993; 402; 409; 383 | — |
| SECONDARY Cobalt and Chromium Ion Levels |
1.41; 2.58; 0.11; 0.71; 1.47; 0.18 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02892448). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.