Myocardial Perfusion ImagingNCT03937921
Dotarem Evaluation for Myocardial Perfusion CMR
An observational study of Myocardial Perfusion Imaging and Magnetic Resonance Imaging, run by Medical University of South Carolina at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myocardial Perfusion Imaging, Magnetic Resonance Imaging
- What is being tested?
- Gadavist 15Ml Solution for Injection
- Type of treatment
- Injection or infusion
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jul 2019to 31 Oct 2024
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- To be eligible for the study: (All answers must be "YES" for subject to be eligible.)
- Subject must be referred for a clinically indicated contrast-enhanced stress myocardial perfusion MRI scan out of concern of suspected myocardial ischemia.
- Subject must be older than 18 years of age.
- Subject must provide written informed consent prior to any study-related procedures being performed.
- Subject must be willing to comply with all clinical study procedures.
- To be eligible for the study: (All answers must be "YES" for subject to be eligible.)
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- Subject must be referred for a clinically indicated contrast-enhanced stress myocardial perfusion MRI scan out of concern of suspected myocardial ischemia.
- Subject must be older than 18 years of age.
- Subject must provide written informed consent prior to any study-related procedures being performed.
- Subject must be willing to comply with all clinical study procedures.
Who cannot join
- 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:
- 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.
- Subject has an implanted cardiac pacemaker or implantable defibrillator.
Show all 40Show fewer
- Subject has a ferromagnetic vascular clip.
- Subject has a neurostimulation system (e.g. TENS-Unit).
- Subject has any type of cochlear implant.
- Subject has ocular foreign body (e.g. metal shavings).
- Subject carries any implanted device (e.g. insulin pump, drug infusion device).
- Subject has shrapnel, bullet, or other type of metal fragments within the body.
- Subject has an acute psychiatric disorder or is cognitively impaired.
- Subject is using or is dependent on substances of abuse.
- Subject is unwilling to comply with the requirements of the protocol.
- Subject is in acute unstable condition.
- Subject has an allergy against gadolinium based contrast agents or pharmaceutical stressors used in this study.
- Subject has impaired renal function (creatinine > 1.5 mg/dl).
- Subject presenting with acute coronary syndrome.
- Positive cardiac enzymes positive troponin, CK-MB, or myosin
- ST-elevations, new transient ST changes greater than 0.05mV or T- wave inversions with symptoms
- Aim 2
- 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:
- 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.
- Subject has an implanted cardiac pacemaker or implantable defibrillator.
- Subject has a ferromagnetic vascular clip.
- Subject has a neurostimulation system (e.g. TENS-Unit).
- Subject has any type of cochlear implant.
- Subject has ocular foreign body (e.g. metal shavings).
- Subject carries any implanted device (e.g. insulin pump, drug infusion device).
- Subject has shrapnel, bullet, or other type of metal fragments within the body.
- Subject has an acute psychiatric disorder or is cognitively impaired.
- Subject is using or is dependent on substances of abuse.
- Subject is unwilling to comply with the requirements of the protocol.
- Subject is in acute unstable condition.
- Subject has an allergy against gadolinium based contrast agents used in this study.
- Subject has impaired renal function (creatinine > 1.5 mg/dl).
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
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.
Read the 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.
- Being tested
- Gadavist 15Ml Solution for Injection
- Keywords
- Signal intensity enhancement, Relaxation rate enhancement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gadavist 15Ml Solution for InjectionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Gadavist 15Ml Solution for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Signal intensity of gadoterate meglumine during perfusion cardiovascular magnetic resonance
Characteristics of signal intensity changes and absolute myocardial blood flow using the MASS Research Software; signal intensity-time curves from the perfusion data
Measured: 1 year
Secondary outcomes (1)
Relaxation rate characteristics of gadoterate meglumine during perfusion cardiovascular magnetic resonance
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start3 Jul 2019
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial Perfusion ImagingStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Guerbet
- Responsible party
- Sponsor
- Investigators
- Joseph U. Schoepf, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03937921
- Sponsor's protocol ID
- 80969
- Status last verified
- Nov 2024
- First submitted
- 17 Apr 2019
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dotarem Evaluation for Myocardial Perfusion CMR
- ClinicalTrials.gov ID
- NCT03937921
- Acronym / sponsor ID
- 80969
- Keywords
- Signal intensity enhancement, Relaxation rate enhancement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Guerbet
- Study start
- 3 Jul 2019 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 6 May 2019 (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.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Drug: Gadavist 15Ml Solution for InjectionGroup 2 (n=30) will receive the clinically approved gadobutrol (Gadavist, 0.1mmol/kg) as the contrast agent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- To be eligible for the study: (All answers must be "YES" for subject to be eligible.)
- Subject must be referred for a clinically indicated contrast-enhanced stress myocardial perfusion MRI scan out of concern of suspected myocardial ischemia.
- Subject must be older than 18 years of age.
- Subject must provide written informed consent prior to any study-related procedures being performed.
- Subject must be willing to comply with all clinical study procedures.
Key exclusion criteria (40 listed)
- 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:
- Subject has an implanted cardiac pacemaker or implantable defibrillator.
- Subject has a ferromagnetic vascular clip.
- Subject has a neurostimulation system (e.g. TENS-Unit).
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 |
|---|---|---|
| Gadavist 15Ml Solution for InjectionGroup 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. | Drug | Group 2 - Gadavist |
Primary outcome
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 secondary outcome
Relaxation rate characteristics of gadoterate meglumine during perfusion cardiovascular magnetic resonance
Time frame: 1 year
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 12 Nov 2024.
- Individual participant dataSharing planned: No
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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.
Joseph U. Schoepf, MD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Perfusion Imaging and Magnetic Resonance Imaging, run by Medical University of South Carolina at 1 site in United States.
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 10 inclusion and 40 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 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Signal intensity of gadoterate meglumine during perfusion cardiovascular magnetic resonance (time frame: 1 year). 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 12 Nov 2024.