Ignite Creation Date:
2024-05-06 @ 9:43 AM
Last Modification Date:
2024-10-26 @ 12:18 PM
Study NCT ID:
NCT03057561
Status:
UNKNOWN
Last Update Posted:
2019-01-22
First Post:
2017-01-18
Brief Title:
Efficacy of Dotarem Gd-DOTA Versus Gadovist Gd-DO3A-butrol for Late Gadolinium Enhancement Cardiac Magnetic Resonance
Sponsor:
Dipan Shah
Organization:
The Methodist Hospital Research Institute
Study Overview
Official Title:
Efficacy of Dotarem Gd-DOTA Versus Gadovist Gd-DO3A-butrol for Late Gadolinium Enhancement Cardiac Magnetic Resonance and Relationship to Outcomes A Pilot Study
Status:
UNKNOWN
Status Verified Date:
2019-01
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This project is designed to demonstrate equivalence of Dotarem enhanced LGE-CMR late gadolinium enhancement cardiac MRI with Gadoviost enhanced LGE-CMR from the standpoint of visual image quality quantitative image quality and association with clinical outcomes
Detailed Description:
Gadolinium-containing contrast agents GdCAs are intravenous agents used for contrast enhancement with magnetic resonance imaging MRI and with magnetic resonance angiography MRA The GdCAs gadodiamide gadopentetic acid gadobenic acid gadoxetic acid gadoteridol gadobutrol and gadoteric acid have been in use for few decades for different types of MR scan varying from product to product including liver brain and whole body scan
Recently there has been a great interest in employing contrast-related techniques to assess for fibrosis in the myocardium of the heart As opposed to nuclear methods viability assessment by MRI is a nonstress examination that provides high-resolution detail including functional assessment of the left ventricle in approximately 30 minutes Assessment of myocardial viability is performed using 5- to 20-minute delayed gadolinium-enhanced MRI On delayed MRI there is a relatively decreased washout of the gadolinium contrast agent in areas of myocardium that have been replaced by fibrosis or scar In normal viable myocardium the gadolinium contrast agent washes out more rapidly than it does from the fibrosis or scar Since the difference between normal and abnormal myocardium is based on washout kinetics images that are delayed by 5 to 20 minutes after contrast injection will optimally depict the fibrosis or scar
The differences in gadolinium enhancement on MRI of viable myocardium and fibrosis or scar have been known for many years Recently however MRI pulse sequences have been developed that greatly improve the conspicuity of the enhanced areas of myocardium that have been replaced by fibrosis or scar The pulse sequence used is an inversion-recovery prepared gradient-echo sequence In this method an inversion pulse is used to null the signal from normal myocardium Myocardium that is replaced by fibrosis or scar retains gadolinium and shows very high signal intensity compared with the suppressed darker myocardium
Gadovist has been the standard gadolinium contrasts used in the US in CMR imaging for the past few years On the other hand Dotarem a widely used contrast agent in Europe has been introduced to be used in the US marketThe sensitivity of Dotarem to that of Magnevist in determining the location and extent of scar in patients scanned with CMR will be Gadovist in this study
The CMR laboratory at the Houston Methodist DeBakey Heart Vascular Center is one of the largest dedicated CMR laboratories in the US performing 3000 clinical CMR procedures per year The laboratory has been in existence since 2008 and is currently equipped with 2 dedicated MRI scanners 15T Siemens Avanto and 30T Siemens Verio Through a research agreement with Siemens Medical Solutions the laboratory has access to numerous works-in progress sequences as they are developed The laboratory is equipped with an MRI compatible patient monitoring system infusion pump and power injector and is staffed by a team of 5 dedicated CMR technologists 2 clinical nurses 1 CMR fellow an MRI scientist and 2 attending cardiologists
One hundred twenty patients with known or suspected cardiovascular disease will be recruited for this study Patients will be randomized in a 11 fashion to receive either Dotarem or Gadovist for LGE-CMR such that there will be 60 patients in the Dotarem cohort and 60 patients in the Gadovist cohort
Recently there has been a great interest in employing contrast-related techniques to assess for fibrosis in the myocardium of the heart As opposed to nuclear methods viability assessment by MRI is a nonstress examination that provides high-resolution detail including functional assessment of the left ventricle in approximately 30 minutes Assessment of myocardial viability is performed using 5- to 20-minute delayed gadolinium-enhanced MRI On delayed MRI there is a relatively decreased washout of the gadolinium contrast agent in areas of myocardium that have been replaced by fibrosis or scar In normal viable myocardium the gadolinium contrast agent washes out more rapidly than it does from the fibrosis or scar Since the difference between normal and abnormal myocardium is based on washout kinetics images that are delayed by 5 to 20 minutes after contrast injection will optimally depict the fibrosis or scar
The differences in gadolinium enhancement on MRI of viable myocardium and fibrosis or scar have been known for many years Recently however MRI pulse sequences have been developed that greatly improve the conspicuity of the enhanced areas of myocardium that have been replaced by fibrosis or scar The pulse sequence used is an inversion-recovery prepared gradient-echo sequence In this method an inversion pulse is used to null the signal from normal myocardium Myocardium that is replaced by fibrosis or scar retains gadolinium and shows very high signal intensity compared with the suppressed darker myocardium
Gadovist has been the standard gadolinium contrasts used in the US in CMR imaging for the past few years On the other hand Dotarem a widely used contrast agent in Europe has been introduced to be used in the US marketThe sensitivity of Dotarem to that of Magnevist in determining the location and extent of scar in patients scanned with CMR will be Gadovist in this study
The CMR laboratory at the Houston Methodist DeBakey Heart Vascular Center is one of the largest dedicated CMR laboratories in the US performing 3000 clinical CMR procedures per year The laboratory has been in existence since 2008 and is currently equipped with 2 dedicated MRI scanners 15T Siemens Avanto and 30T Siemens Verio Through a research agreement with Siemens Medical Solutions the laboratory has access to numerous works-in progress sequences as they are developed The laboratory is equipped with an MRI compatible patient monitoring system infusion pump and power injector and is staffed by a team of 5 dedicated CMR technologists 2 clinical nurses 1 CMR fellow an MRI scientist and 2 attending cardiologists
One hundred twenty patients with known or suspected cardiovascular disease will be recruited for this study Patients will be randomized in a 11 fashion to receive either Dotarem or Gadovist for LGE-CMR such that there will be 60 patients in the Dotarem cohort and 60 patients in the Gadovist cohort
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None