Efficacy of Dotarem® (Gd-DOTA) Versus Gadovist® (Gd-DO3A-butrol) for Late Gadolinium Enhancement Cardiac Magnetic Resonance

NCT03057561 | Completed

• 1 other identifier: Pro00012234
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coronary Artery Disease; Cardiomyopathy

Keywords

CAD

Outcome Measures

Primary Outcomes (3)

• Compare visual image quality of LGE-CMR when performed with Dotarem or Gadovist in a randomized fashion.

  All LGE-CMR scans scoring for visual image quality using a 5-point scale: 1 = LV myocardium not visible, 2 = severe artifact interfering with ability to visualize LV myocardial borders limiting assessment for presence of LGE (poor), 3 = LV myocardial borders are well delineated but there is moderate artifact affecting ability to identify LGE (fair), 4 = LV myocardium is well delineated with minor artifacts affecting ability to identify LGE (good), 5 = LV myocardium well delineated with no artifacts affecting ability to identify LGE (excellent).

  Two years

• Compare quantitative signal enhancement of LGE when performed with Dotarem or Gadovist in a randomized fashion.

  Assessment of the intensity of hyperenhancement with Dotarem and Gadovist using a semi-automated computer software.

  Two Years

• Compare association of LGE and clinical cardiovascular outcomes when performed with Dotarem or Gadovistin a randomized fashion.

  Patient screened for outcomes (e.g. acute myocardial infraction, sudden cardiac death, heart failure, stroke, cardiovascular hemorrhage, other death from cardiovascular causes)

  Eight years

Study Arms (2)

3.0 Tesla Cardiac MRI using Dotarem contrast agent

EXPERIMENTAL

60 randomly selected participants with suspected or known cardiovascular disease will have a 3.0 Tesla Cardiac MRI with contrast agent, Dotarem

Drug: Cardiac MRI taken using contrast agent, Dotarem® (Gd-DOTA); Drug: Cardiac MRI with contrast agent, Gadovist

3.0 Tesla Cardiac MRI using a Gadovist contrast agent

EXPERIMENTAL

60 randomly selected participants with suspected or known cardiovascular disease will have a 3.0 Tesla Cardiac MRI with contrast agent, Gadovist

Drug: Cardiac MRI taken using contrast agent, Dotarem® (Gd-DOTA); Drug: Cardiac MRI with contrast agent, Gadovist

Interventions

Cardiac MRI taken using contrast agent, Dotarem® (Gd-DOTA) DRUG

Gadolinium based contrast agent used in cardiac MRI scanning using 3.0 Tesla MRI

Also known as: Cardiac MRI with contrast, CMR with tracer or contrast agent, Dotarem (Gd-DOTA) contrast agent

3.0 Tesla Cardiac MRI using Dotarem contrast agent; 3.0 Tesla Cardiac MRI using a Gadovist contrast agent

Cardiac MRI with contrast agent, Gadovist DRUG

Brand of Gd-DO3A-butrol; contrast agent used in cardiac MRI scanning using 3.0 Tesla MRI

Also known as: Cardiac MRI with contrast, CMR with tracer or contrast agent, Gadovist® (Gd-DO3A-butrol) contast agent

3.0 Tesla Cardiac MRI using Dotarem contrast agent; 3.0 Tesla Cardiac MRI using a Gadovist contrast agent

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing clinically referred CMR.

You may not qualify if:

• Patients who are unable to give informed consent.
• Individuals with severe claustrophobia.
• Individuals unable to lie flat for 90 minutes (the anticipated amount of time to complete the MRI procedure).
• Individuals who are pregnant.
• Patients with implants or pacemakers.
• Patients that have hypersensitivity to components of gadolinium.
• Patients with renal failure.
• Patients who had any trauma or surgery which may have left ferromagnetic material in the body.

Sponsors & Collaborators

• Guerbet: collaborator
• The Methodist Hospital Research Institute: lead

MeSH Terms

Conditions

Coronary Artery Disease; Cardiomyopathies

Interventions

gadoterate meglumine; gadolinium 1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetate; Contrast Media; Product Labeling; gadobutrol

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Uses of Chemicals; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Product Packaging; Industry; Technology, Industry, and Agriculture

Study Officials

• Dipan Shah, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinded reader of scans will not know whether subject received Dotarem or Gadovist.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Cardiac Magnetic Resonance Imaging

Model Details: Evaluating the efficacy of Dotarem enhanced MRI compared to Gadovist enhanced MRI in identifying myocardial fibrosis. Patients will be randomized (in a 1:1 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 Record Dates

• First Submitted: January 18, 2017
• First Posted: February 20, 2017
• Study Start: October 1, 2016
• Primary Completion: December 31, 2020
• Study Completion: June 30, 2021
• Last Updated: April 20, 2026

Record last verified: 2026-04