The overall goal of this study is to investigate the signal intensity and relaxation rate characteristics of gadoterate meglumine (Dotarem, Guerbet, USA) enhanced myocardium during rest and stress perfusion cardiovascular magnetic resonance (CMR) compared to gadobutrol (Gadavist) to prove that Dotarem provides constantly high myocardial relaxation necessary for accurate quantitative perfusion evaluation.
The purpose of this study is to compare two types of contrast that patients receive during cardiac MRI scans to visualize the blood flow in the cardiac muscle. Both contrasts are used in standard of care procedures, and the one administered for each patient will be randomly selected. The length of the MRI study all procedures are the same as the clinically indicated scan.
Condition or disease | Intervention/treatment |
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Myocardial Perfusion Imaging Magnetic Resonance Imaging | Drug: Gadavist 15Ml Solution for Injection |
The overall goal of this study is to investigate the signal intensity and relaxation rate characteristics of gadoterate meglumine (Dotarem, Guerbet, USA) enhanced myocardium during rest and stress perfusion cardiovascular magnetic resonance (CMR) compared to gadobutrol (Gadavist) to prove that Dotarem provides constantly high myocardial relaxation necessary for accurate quantitative perfusion evaluation. Within this overall goal, the following specific aims will be pursued:
Study Type : | Observational |
Estimated Enrollment : | 90 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | Dotarem Evaluation for Myocardial Perfusion CMR |
Actual Study Start Date : | July 3, 2019 |
Estimated Primary Completion Date : | April 30, 2022 |
Estimated Study Completion Date : | April 30, 2022 |
Group/Cohort | Intervention/treatment |
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Group 1 - Dotarem
Group 1 (n=30) will receive the clinically approved gadoterate meglumine (Dotarem, 0.1mmol/kg) as the contrast agent for their clinical perfusion study
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Group 2 - Gadavist
Group 2 (n=30) will receive the clinically approved gadobutrol (Gadavist, 0.1mmol/kg) as the contrast agent.
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Drug: Gadavist 15Ml Solution for Injection
Group 2 (n=30) will receive the clinically approved gadobutrol (Gadavist, 0.1mmol/kg) as contrast agent. The contrast agents will be administered at a flow rate of 5.0 ml/s for both groups. In this study aim, all imaging protocols will comply with standard of care and only the perfusion data will be post-processed and analyzed.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
Aim 1
Inclusion criteria:
To be eligible for the study: (All answers must be "YES" for subject to be eligible.)
Exclusion Criteria:
The presence of the following excludes subjects from the study: (All answers must be "NO" for subject to be eligible.)
Subject is a pregnant or nursing female. Exclude the possibility of pregnancy:
Aim 2
Inclusion criteria:
To be eligible for the study: (All answers must be "YES" for subject to be eligible.)
Exclusion Criteria:
The presence of the following excludes subjects from the study: (All answers must be "NO" for subject to be eligible.)
Subject is a pregnant or nursing female. Exclude the possibility of pregnancy:
Contact: Danielle Dargis | 843-876-3185 | dargis@musc.edu | |
Contact: Tyler Leonard | 843-876-4922 | leonarty@musc.edu |
United States, South Carolina | |
Medical University of South Carolina | Recruiting |
Charleston, South Carolina, United States, 29425 | |
Contact: Danielle Dargis 843-876-4922 dargis@musc.edu | |
Contact: Tyler Leonard 843-876-4922 leornarty@musc.edu | |
Principal Investigator: U. Joseph Schoepf | |
Sub-Investigator: Akos Varga-Szemes |
Tracking Information | |||||||||
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First Submitted Date | April 17, 2019 | ||||||||
First Posted Date | May 6, 2019 | ||||||||
Last Update Posted Date | April 30, 2021 | ||||||||
Actual Study Start Date | July 3, 2019 | ||||||||
Estimated Primary Completion Date | April 30, 2022 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures |
Signal intensity of gadoterate meglumine during perfusion cardiovascular magnetic resonance [ Time Frame: 1 year ] Characteristics of signal intensity changes and absolute myocardial blood flow using the MASS Research Software; signal intensity-time curves from the perfusion data
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Original Primary Outcome Measures | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures |
Relaxation rate characteristics of gadoterate meglumine during perfusion cardiovascular magnetic resonance [ Time Frame: 1 year ] The uniformity of T1 and R1 (inverse T1) evaluated using the MASS Research Software; equilibrium T1 maps generated by pre-contrast T1 and repeat inversion recovery images during the perfusion of the coronary arteries
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Original Secondary Outcome Measures | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title | Dotarem Evaluation for Myocardial Perfusion CMR | ||||||||
Official Title | Dotarem Evaluation for Myocardial Perfusion CMR | ||||||||
Brief Summary |
The overall goal of this study is to investigate the signal intensity and relaxation rate characteristics of gadoterate meglumine (Dotarem, Guerbet, USA) enhanced myocardium during rest and stress perfusion cardiovascular magnetic resonance (CMR) compared to gadobutrol (Gadavist) to prove that Dotarem provides constantly high myocardial relaxation necessary for accurate quantitative perfusion evaluation. The purpose of this study is to compare two types of contrast that patients receive during cardiac MRI scans to visualize the blood flow in the cardiac muscle. Both contrasts are used in standard of care procedures, and the one administered for each patient will be randomly selected. The length of the MRI study all procedures are the same as the clinically indicated scan. |
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Detailed Description |
The overall goal of this study is to investigate the signal intensity and relaxation rate characteristics of gadoterate meglumine (Dotarem, Guerbet, USA) enhanced myocardium during rest and stress perfusion cardiovascular magnetic resonance (CMR) compared to gadobutrol (Gadavist) to prove that Dotarem provides constantly high myocardial relaxation necessary for accurate quantitative perfusion evaluation. Within this overall goal, the following specific aims will be pursued:
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Study Type | Observational | ||||||||
Study Design | Observational Model: Case-Control Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||||||
Biospecimen | Not Provided | ||||||||
Sampling Method | Probability Sample | ||||||||
Study Population | There will not be any eligibility criteria for any subpopulations. In addition, there will not be any targeted involvement of special classes of subjects, such as fetuses, neonates, pregnant women, children, prisoners, institutionalized individuals, or others who may be considered vulnerable populations. All race and ethnicities and both genders will be considered for inclusion into the study. Subjects under the age of 18 will not be considered for inclusion into this study. | ||||||||
Condition |
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Intervention | Drug: Gadavist 15Ml Solution for Injection
Group 2 (n=30) will receive the clinically approved gadobutrol (Gadavist, 0.1mmol/kg) as contrast agent. The contrast agents will be administered at a flow rate of 5.0 ml/s for both groups. In this study aim, all imaging protocols will comply with standard of care and only the perfusion data will be post-processed and analyzed.
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Study Groups/Cohorts |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status | Recruiting | ||||||||
Estimated Enrollment |
90 | ||||||||
Original Estimated Enrollment | Same as current | ||||||||
Estimated Study Completion Date | April 30, 2022 | ||||||||
Estimated Primary Completion Date | April 30, 2022 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria |
Aim 1 Inclusion criteria: To be eligible for the study: (All answers must be "YES" for subject to be eligible.)
Exclusion Criteria: The presence of the following excludes subjects from the study: (All answers must be "NO" for subject to be eligible.)
Aim 2 Inclusion criteria: To be eligible for the study: (All answers must be "YES" for subject to be eligible.)
Exclusion Criteria: The presence of the following excludes subjects from the study: (All answers must be "NO" for subject to be eligible.)
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers | Yes | ||||||||
Contacts |
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Listed Location Countries | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number | NCT03937921 | ||||||||
Other Study ID Numbers | 80969 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | U. Joseph Schoepf, MD, Medical University of South Carolina | ||||||||
Study Sponsor | Medical University of South Carolina | ||||||||
Collaborators | Guerbet | ||||||||
Investigators | Not Provided | ||||||||
PRS Account | Medical University of South Carolina | ||||||||
Verification Date | April 2021 |