Coronary Artery DiseaseNCT03057561
Efficacy of Dotarem® (Gd-DOTA) Versus Gadovist® (Gd-DO3A-butrol) for Late Gadolinium Enhancement Cardiac Magnetic Resonance
A study testing Cardiac MRI taken using contrast agent, Dotarem® (Gd-DOTA) and Cardiac MRI with contrast agent, Gadovist in people with Coronary Artery Disease and Cardiomyopathy, run by The Methodist Hospital Research Institute.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Coronary Artery Disease, Cardiomyopathy
- What is being tested?
- Cardiac MRI taken using contrast agent, Dotarem® (Gd-DOTA) and Cardiac MRI with contrast agent, Gadovist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2016to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing clinically referred CMR.
Who cannot join
- 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.
About this study
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
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.
Read the 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 U.S. 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 U.S. market.The 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 U.S. performing 3,000 clinical CMR procedures per year. The laboratory has been in existence since 2008 and is currently equipped with 2 dedicated MRI scanners: 1.5T Siemens Avanto and 3.0T 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 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.
- Conditions
- Coronary Artery Disease, Cardiomyopathy
- Being tested
- Cardiac MRI taken using contrast agent, Dotarem® (Gd-DOTA), Cardiac MRI with contrast agent, Gadovist
- Keywords
- CAD
- Medical subject headings
- Coronary Artery Disease, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac MRI taken using contrast agent, Dotarem® (Gd-DOTA)Drug
Also called Cardiac MRI with contrast, CMR with tracer or contrast agent, Dotarem (Gd-DOTA) contrast agent
Gadolinium based contrast agent used in cardiac MRI scanning using 3.0 Tesla MRI
Cardiac MRI with contrast agent, GadovistDrug
Also called Cardiac MRI with contrast, CMR with tracer or contrast agent, Gadovist® (Gd-DO3A-butrol) contast agent
Brand of Gd-DO3A-butrol; contrast agent used in cardiac MRI scanning using 3.0 Tesla MRI
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Cardiac MRI taken using contrast agent, Dotarem® (Gd-DOTA); Drug: Cardiac MRI with contrast agent, Gadovist |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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)
Measured: Eight years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2017
- Study start1 Oct 2016
- Primary completion31 Dec 2020
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by The Methodist Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Guerbet
- Responsible party
- Principal investigator, Dipan Shah, The Methodist Hospital Research Institute
- Investigators
- Dipan Shah, MD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03057561
- Sponsor's protocol ID
- Pro00012234
- Status last verified
- Apr 2026
- First submitted
- 18 Jan 2017
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03057561
- Acronym / sponsor ID
- Pro00012234
- Conditions
- Coronary Artery Disease, Cardiomyopathy
- Keywords
- CAD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Guerbet
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 20 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 U.S. 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 U.S. market.The 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 U.S. performing 3,000 clinical CMR procedures per year. The laboratory has been in existence since 2008 and is currently equipped with 2 dedicated MRI scanners: 1.5T Siemens Avanto and 3.0T 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 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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| 3.0 Tesla Cardiac MRI using Dotarem contrast agent | Experimental | Drug: Cardiac MRI taken using contrast agent, Dotarem® (Gd-DOTA), Drug: Cardiac MRI with contrast agent, Gadovist60 randomly selected participants with suspected or known cardiovascular disease will have a 3.0 Tesla Cardiac MRI with contrast agent, Dotarem |
| 3.0 Tesla Cardiac MRI using a Gadovist contrast agent | Experimental | Drug: Cardiac MRI taken using contrast agent, Dotarem® (Gd-DOTA), Drug: Cardiac MRI with contrast agent, Gadovist60 randomly selected participants with suspected or known cardiovascular disease will have a 3.0 Tesla Cardiac MRI with contrast agent, Gadovist |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing clinically referred CMR.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac MRI taken using contrast agent, Dotarem® (Gd-DOTA)Also: Cardiac MRI with contrast, CMR with tracer or contrast agent, Dotarem (Gd-DOTA) contrast agentGadolinium based contrast agent used in cardiac MRI scanning using 3.0 Tesla MRI | Drug | 3.0 Tesla Cardiac MRI using Dotarem contrast agent, 3.0 Tesla Cardiac MRI using a Gadovist contrast agent |
| Cardiac MRI with contrast agent, GadovistAlso: Cardiac MRI with contrast, CMR with tracer or contrast agent, Gadovist® (Gd-DO3A-butrol) contast agentBrand of Gd-DO3A-butrol; contrast agent used in cardiac MRI scanning using 3.0 Tesla MRI | Drug | 3.0 Tesla Cardiac MRI using Dotarem contrast agent, 3.0 Tesla Cardiac MRI using a Gadovist contrast agent |
Primary outcome
Compare visual image quality of LGE-CMR when performed with Dotarem or Gadovist in a randomized fashion.
Time frame: Two years
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).
Compare quantitative signal enhancement of LGE when performed with Dotarem or Gadovist in a randomized fashion.
Time frame: Two Years
Assessment of the intensity of hyperenhancement with Dotarem and Gadovist using a semi-automated computer software.
Compare association of LGE and clinical cardiovascular outcomes when performed with Dotarem or Gadovistin a randomized fashion.
Time frame: Eight years
Patient screened for outcomes (e.g. acute myocardial infraction, sudden cardiac death, heart failure, stroke, cardiovascular hemorrhage, other death from cardiovascular causes)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dipan Shah, MD principal investigator
The Methodist Hospital Research Institute
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac MRI taken using contrast agent, Dotarem® (Gd-DOTA) and Cardiac MRI with contrast agent, Gadovist in people with Coronary Artery Disease and Cardiomyopathy, run by The Methodist Hospital Research Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare visual image quality of LGE-CMR when performed with Dotarem or Gadovist in a randomized fashion. (time frame: Two years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.