CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 35 enrolled
Drug / intervention
Cardiac magnetic resonance imaging (CMR)other
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02892448
NCT02892448N/ACompleted

Cardiac MRI for Metal on Metal Orthopaedic Prostheses

Ottawa Hospital Research Institute·interventional·Posted Sep 8, 2016·Updated Aug 24, 2020

In Brief

A clinical study evaluating Cardiac magnetic resonance imaging (CMR) for Cardiomyopathy. Completed, enrolled 35 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCardiomyopathy
CountriesCanada

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedSep 8, 2016
Enrollment StartSep 1, 2016
Primary CompletionJul 20, 2019
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 9.8 years ago

Interventions

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.