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Dotarem Evaluation for Myocardial Perfusion CMR

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03937921
Recruitment Status : Recruiting
First Posted : May 6, 2019
Last Update Posted : July 7, 2020
Sponsor:
Collaborator:
Guerbet
Information provided by (Responsible Party):
U. Joseph Schoepf, MD, Medical University of South Carolina

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.


Condition or disease Intervention/treatment
Myocardial Perfusion Imaging Magnetic Resonance Imaging Drug: Gadavist 15Ml Solution for Injection

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:

  • Aim 1: To test the hypothesis that the signal intensity enhancement during Dotarem myocardial stress/rest perfusion is relatively constant, providing linear and stable enhancement in the myocardium, and is not inferior compared to gadobutrol (Gadavist).
  • Aim 2: To test the hypothesis that the relaxation rate enhancement during Dotarem myocardial rest perfusion is uniform in the myocardium.

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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, 2021
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Group 2 - Gadavist
Group 2 (n=30) will receive the clinically approved gadobutrol (Gadavist, 0.1mmol/kg) as the contrast agent.
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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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
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.
Criteria

Aim 1

Inclusion criteria:

To be eligible for the study: (All answers must be "YES" for subject to be eligible.)

  1. Subject must be referred for a clinically indicated contrast-enhanced stress myocardial perfusion MRI scan out of concern of suspected myocardial ischemia.
  2. Subject must be older than 18 years of age.
  3. Subject must provide written informed consent prior to any study-related procedures being performed.
  4. Subject must be willing to comply with all clinical study procedures.

Exclusion Criteria:

The presence of the following excludes subjects from the study: (All answers must be "NO" for subject to be eligible.)

  1. Subject is a pregnant or nursing female. Exclude the possibility of pregnancy:

    • By testing (serum or urine beta HCG) within 24 hours before study date, or
    • By surgical sterilization, or
    • Post-menopausal, with minimum one (1) year history without menses.
  2. Subject has an implanted cardiac pacemaker or implantable defibrillator.
  3. Subject has a ferromagnetic vascular clip.
  4. Subject has a neurostimulation system (e.g. TENS-Unit).
  5. Subject has any type of cochlear implant.
  6. Subject has ocular foreign body (e.g. metal shavings).
  7. Subject carries any implanted device (e.g. insulin pump, drug infusion device).
  8. Subject has shrapnel, bullet, or other type of metal fragments within the body.
  9. Subject has an acute psychiatric disorder or is cognitively impaired.
  10. Subject is using or is dependent on substances of abuse.
  11. Subject is unwilling to comply with the requirements of the protocol.
  12. Subject is in acute unstable condition.
  13. Subject has an allergy against gadolinium based contrast agents or pharmaceutical stressors used in this study.
  14. Subject has impaired renal function (creatinine > 1.5 mg/dl).
  15. Subject presenting with acute coronary syndrome.
  16. Positive cardiac enzymes positive troponin, CK-MB, or myosin
  17. ST-elevations, new transient ST changes greater than 0.05mV or T- wave inversions with symptoms

Aim 2

Inclusion criteria:

To be eligible for the study: (All answers must be "YES" for subject to be eligible.)

  1. Subject must be referred for a clinically indicated contrast-enhanced stress myocardial perfusion MRI scan out of concern of suspected myocardial ischemia.
  2. Subject must be older than 18 years of age.
  3. Subject must provide written informed consent prior to any study-related procedures being performed.
  4. Subject must be willing to comply with all clinical study procedures.

Exclusion Criteria:

The presence of the following excludes subjects from the study: (All answers must be "NO" for subject to be eligible.)

  1. Subject is a pregnant or nursing female. Exclude the possibility of pregnancy:

    • By testing (serum or urine beta HCG) within 24 hours before study date, or
    • By surgical sterilization, or
    • Post-menopausal, with minimum one (1) year history without menses.
  2. Subject has an implanted cardiac pacemaker or implantable defibrillator.
  3. Subject has a ferromagnetic vascular clip.
  4. Subject has a neurostimulation system (e.g. TENS-Unit).
  5. Subject has any type of cochlear implant.
  6. Subject has ocular foreign body (e.g. metal shavings).
  7. Subject carries any implanted device (e.g. insulin pump, drug infusion device).
  8. Subject has shrapnel, bullet, or other type of metal fragments within the body.
  9. Subject has an acute psychiatric disorder or is cognitively impaired.
  10. Subject is using or is dependent on substances of abuse.
  11. Subject is unwilling to comply with the requirements of the protocol.
  12. Subject is in acute unstable condition.
  13. Subject has an allergy against gadolinium based contrast agents used in this study.
  14. Subject has impaired renal function (creatinine > 1.5 mg/dl).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03937921


Contacts
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Contact: Danielle Dargis 843-876-3185 dargis@musc.edu
Contact: Tyler Leonard 843-876-4922 leonarty@musc.edu

Locations
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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         
Sponsors and Collaborators
Medical University of South Carolina
Guerbet
  Study Documents (Full-Text)

Documents provided by U. Joseph Schoepf, MD, Medical University of South Carolina:
Informed Consent Form  [PDF] October 24, 2018

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Responsible Party: U. Joseph Schoepf, MD, Director of the Division of Cardiovascular Imaging, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03937921    
Other Study ID Numbers: 80969
First Posted: May 6, 2019    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by U. Joseph Schoepf, MD, Medical University of South Carolina:
Signal intensity enhancement
Relaxation rate enhancement