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View Clinical Trial (Medical Research Study)
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Effects of Body Mass Index on the Hyperemic Response to Regadenoson - NCT00859833-84132 (Clinical Trial 277123)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy277123.aspx
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| City: |
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Salt Lake City |
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State:
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UT |
| Zip Code: |
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84132 |
| Conditions: |
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Obesity - Endothelial Function |
| Purpose: |
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We will test the hypothesis that a single dose of Regadenoson will produce equivalent
degrees of coronary hyperemia in patients of widely different body size. This will be a
prospective, open-label, comparative trial using MRI. Non-invasive MRI measurements of
resting flow, flow at adenosine stress (weight adjusted dosing), and flow at regadenoson
stress (single dose) will be obtained in each subject during a two hour MRI exam. 32
subjects will be recruited for this study. Inclusion criteria: 15 subjects with BMI between
20-30, and 15 subjects with BMI between 34-40. When possible, patients with suspected
coronary artery disease that will have corresponding catheterization X-ray angiography data
will be recruited to participate in this study
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| Study summary: |
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Introduction: Regadenoson (Lexiscan) is currently recommended for use as a targeted
vasodilator in myocardial perfusion studies and is available as a single-sized dose for all
patients. Part of the data showing that a single dose is adequate for all patients is based
on Gordi et al. [2]. That study used 36 relatively thin subjects, with a mean body mass
index BMI=24.4±3.0. Here we propose to compare the hyperemic response with MRI in two groups
of subjects, one with BMI 20-30, and another group with BMI 34-40.
MRI is the ideal test to compare the effects of regadenoson in patients with different body
mass indices (BMIs). No radiation is used and multiple perfusion tests can be performed.
Importantly, a number of researchers have shown the ability to obtain quantitative stress
and rest flow values in the heart with MR imaging, and to measure perfusion reserve. Flow
reserve measurements also can be done with dynamic PET, but not with SPECT.
In addition, regadenoson may be a more desirable agent for use with MRI than is adenosine.
Adenosine requires starting a second IV, and to use either a special expensive
MRI-compatible infusion pump to deliver the drug, or long lengths of tubing to run to a pump
outside the scanner room. Neither solution is ideal, and regadenoson would not require any
such pumps or the starting of a second IV. The work here would indicate the feasibility of
performing quantitative MRI perfusion measurements with regadenoson.
Study Design: This will be a prospective, open-label, comparative trial using MRI.
Non-invasive MRI measurements of resting flow, flow at adenosine stress, and flow at
regadenoson stress will be obtained in each subject during a two hour MRI exam.
32 subjects will be recruited for this study. The first two subjects will be imaged only
with resting perfusion, in order to determine optimal acquisition parameters for the study,
and will not be used in the analysis. |
| Criteria: |
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Inclusion Criteria:
- BMI 20-40 kg/m^2.
Exclusion Criteria:
- critically ill patients, patients on ventilators, patients with hypotension,
asthmatics, and other patients whose medical care or safety may be compromised from
undergoing an MRI examination will be excluded.
- Patients with claustrophobia will also be excluded.
- Also, anyone with contraindications to MRI (pacemaker, ICD, metal implants), pregnant
subjects, minors, and prisoners will be excluded from this study.
- If subjects are over 60 or have any suspicion of abnormal kidney function, a blood
test to determine GFR will be performed prior to imaging.
- Subjects with GFR < 30 will be excluded from the study. |
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| Study is available at: |
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University of Utah
Salt Lake City, UT 84132
United States
Primary Contact:
Sheldon Litwin, MD
Email: sheldon.litwin@hsc.utah.edu
Phone: 8015817715 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 16, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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