Effects of Body Mass Index on the Hyperemic Response to Regadenoson - Full Text View

Sponsor:	University of Utah
Collaborator:	Astellas Pharma Inc
Information provided by:	University of Utah
ClinicalTrials.gov Identifier:	NCT00859833

Purpose

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

Condition	Intervention
Obesity Endothelial Function	Other: Diagnostic MRI

Study Type:	Interventional
Study Design:	Diagnostic, Single Blind (Outcomes Assessor), Dose Comparison, Parallel Assignment, Bio-equivalence Study
Official Title:	Effects of Body Mass Index on the Hyperemic Response to Regadenoson

Resource links provided by NLM:

MedlinePlus related topics: Obesity

Drug Information available for: Adenosine CVT 3146

U.S. FDA Resources

Further study details as provided by University of Utah:

Primary Outcome Measures:

Coronary flow reserve measured by quantitative perfusion MRI. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	32
Study Start Date:	February 2009
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Coronary flow reserve: Experimental	Other: Diagnostic MRI MRI done with adenosine and with regadenoson and compared

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 88 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00859833

Contacts

Contact: Sheldon Litwin, MD	8015817715	sheldon.litwin@hsc.utah.edu
Contact: Edward DiBella, PhD		Ed@ucair.med.utah.edu

Locations

United States, Utah
University of Utah	Recruiting
Salt Lake City, Utah, United States, 84132

Sponsors and Collaborators

University of Utah

Astellas Pharma Inc

Investigators

Principal Investigator:

Sheldon E Litwin, MD

University of Utah

More Information

No publications provided

Responsible Party:	University of Utah ( Sheldon Litwin, M.D., Professor of Medicine )
Study ID Numbers:	31431
Study First Received:	March 10, 2009
Last Updated:	November 24, 2009
ClinicalTrials.gov Identifier:	NCT00859833 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Utah:

Obesity
Endothelial function
Coronary flow reserve

Adenosine
Adenosine receptor subtypes
Regadenoson

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Obesity

Nutrition Disorders
Overweight
Overnutrition

ClinicalTrials.gov processed this record on February 08, 2010