Effects of Body Mass Index on the Hyperemic Response to Regadenoson
Completed · Not applicable
Conditions studied: Obesity, Endothelial Dysfunction, Decreased Vascular Flow
In brief
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 to measure myocardial perfusion reserve (ratio of myocardial blood flow with vasodilator to myocardial blood flow at rest) during sequential administration of the coronary vasodilators adenosine and regadenoson. Non-invasive MRI measurements of resting myocardial blood flow, and sequential measurements of blood flow during adenosine infusion (weight adjusted dosing) and then blood flow during regadenoson infusion (single, fixed dose. Blood flow measurements will be obtained sequentially and in the same sequence in each subject during a two hour MRI exam. 32 subjects will be recruited for this study. The first 2 will be for testing of the protocol. Inclusion criteria: 2 subjects for initial protocol evaluation, then 30 subjects with body mass index (BMI) between 18 and 40. Exclusions are pregnancy, renal dysfunction and claustrophobia.
Key facts
- Study ID
- NCT00859833
- Run by
- University of Utah
- People needed
- 30
- Starts
- 2009-02-01
- Expected to finish
- 2010-07-01
- Last updated by the study team
- 2011-05-24
Who can join
Age: 18 and older, up to 88. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- BMI 20-40 kg/m\^2
- age 18-88
You may not qualify if…
- 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.
Where it is running
- University of Utah — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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