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| Name | Class |
|---|---|
| Guerbet | INDUSTRY |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gadavist 15Ml Solution for Injection | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 year |
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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:
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 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
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:
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).
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Joseph U. Schoepf, MD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 24, 2018 | Apr 29, 2019 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 24, 2018 | Apr 29, 2019 | ICF_001.pdf |
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| ID | Term |
|---|---|
| C090600 | gadobutrol |
| D012996 | Solutions |
| D007267 | Injections |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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