Dotarem Evaluation for Myocardial Perfusion CMR

December 5, 2023 updated by: U. Joseph Schoepf, MD, Medical University of South Carolina

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.

Study Overview

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.

Study Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mark Ghent, BA
  • Phone Number: 843-876-7148
  • Email: ghent@musc.edu

Study Contact Backup

Study Locations

    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
        • Contact:
        • Principal Investigator:
          • U. Joseph Schoepf
        • Sub-Investigator:
          • Akos Varga-Szemes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 3, 2019

Primary Completion (Estimated)

October 30, 2024

Study Completion (Estimated)

October 30, 2024

Study Registration Dates

First Submitted

April 17, 2019

First Submitted That Met QC Criteria

May 1, 2019

First Posted (Actual)

May 6, 2019

Study Record Updates

Last Update Posted (Estimated)

December 6, 2023

Last Update Submitted That Met QC Criteria

December 5, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 80969

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Magnetic Resonance Imaging

Clinical Trials on Gadavist 15Ml Solution for Injection

3
Subscribe