Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
90 participants
OBSERVATIONAL
2019-07-03
2024-10-31
Brief Summary
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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
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* 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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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
No interventions assigned to this group
Group 2 - Gadavist
Group 2 (n=30) will receive the clinically approved gadobutrol (Gadavist, 0.1mmol/kg) as the contrast agent.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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.
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
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
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).
18 Years
ALL
Yes
Sponsors
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Guerbet
INDUSTRY
Medical University of South Carolina
OTHER
Responsible Party
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Principal Investigators
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Joseph U. Schoepf, MD
Role: PRINCIPAL_INVESTIGATOR
Medical University of South Carolina
Locations
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Medical University of South Carolina
Charleston, South Carolina, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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80969
Identifier Type: -
Identifier Source: org_study_id
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