NCT02892448

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2016

Completed
28 days until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 8, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2019

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

August 24, 2020

Completed
Last Updated

August 24, 2020

Status Verified

July 1, 2020

Enrollment Period

2.9 years

First QC Date

August 4, 2016

Results QC Date

April 24, 2020

Last Update Submit

July 28, 2020

Conditions

Cardiomyopathy

Outcome Measures

Primary Outcomes (4)

  • Cardiac Ejection Fraction

    The volumetric fraction of fluid ejected from a chamber with each contraction.

    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

    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.

    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.

    One time measure at CMR

Secondary Outcomes (1)

  • Cobalt and Chromium Ion Levels

    Immediately Prior to cardiac MRI

Study Arms (3)

Unilateral Hip Resurfacing

ACTIVE COMPARATOR

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)

Bilateral Hip Resurfacing

ACTIVE COMPARATOR

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)

Non-Metal on Metal Total Hip

ACTIVE COMPARATOR

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)

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.

Bilateral Hip ResurfacingNon-Metal on Metal Total HipUnilateral Hip Resurfacing

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Paul E Beaule

Ottawa, Ontario, K1H8L6, Canada

Location

Related Publications (5)

  • 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.

    PMID: 21543699BACKGROUND

  • 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.

    PMID: 24124732BACKGROUND

  • 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.

    PMID: 17896383BACKGROUND

  • 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.

    PMID: 1549039BACKGROUND

  • 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.

    PMID: 31039002RESULT

MeSH Terms

Conditions

Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Results Point of Contact

Title
Dr. Paul E Beaule
Organization
The Ottawa Hospital Research Institute
pbeaule@toh.ca
613-737-8899

Study Officials

  • Paul E Beaule, MD, FRCSC

    The Ottawa Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2016

First Posted

September 8, 2016

Study Start

September 1, 2016

Primary Completion

July 20, 2019

Study Completion

July 20, 2019

Last Updated

August 24, 2020

Results First Posted

August 24, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)