Effects of Body Mass Index on the Hyperemic Response to Regadenoson

NCT00859833 | Completed Results

• 1 other identifier: 31431
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity; Endothelial Dysfunction; Decreased Vascular Flow

Keywords

adenosine; regadenoson; adenosine receptor subtypes

Outcome Measures

Primary Outcomes (1)

• Myocardial Perfusion Reserve Measured by Quantitative Perfusion MRI (Ratio of Myocardial Blood Flow During Stress Over Myocardial Blood Flow at Rest)

  The ratio of myocardial blood flow during stress (with each vasodilator) divided by the myocardial flood flow at rest = myocardial perfusion reserve (MPR)

  2 hours

Study Arms (1)

myocardial perfusion reserve

EXPERIMENTAL

Myocardial perfusion reserve will be measured by quantifying myocardial blood flow using MRI at rest and then with each of 2 coronary vasodilators. Measurements are performed with first pass gadolinium perfusion (i.v. bolus injection of 0.02 or 0.03 mmol/kg of gadolinium). Each of the 2 drugs is given sequentially (30 minutes apart) in the same sequence in every patient. The shorter acting drug (adenosine) is given first so it has time to wear off before giving the second drug. It is ideal to measure MPR with each drug during the same imaging session so that there are no other clinical variables that change between the administration of the 2 agents. See below.

Drug: Adenosine; Drug: Regadenoson

Interventions

Adenosine DRUG

Myocardial perfusion reserve measured with quantitative MRI during adenosine infusion (0.14 mg/kg/min x 6 minutes).

Also known as: adenoscan

myocardial perfusion reserve

Regadenoson DRUG

Myocardial perfusion reserve measured during regadenoson (0.4 mg/5 ml) bolus administration using quantitative perfusion MRI.

Also known as: Lexiscan

myocardial perfusion reserve

Eligibility Criteria

• Age: 18 Years - 88 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Utah: lead
• Astellas Pharma Inc: collaborator

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Related Publications (1)

• DiBella EV, Fluckiger JU, Chen L, Kim TH, Pack NA, Matthews B, Adluru G, Priester T, Kuppahally S, Jiji R, McGann C, Litwin SE. The effect of obesity on regadenoson-induced myocardial hyperemia: a quantitative magnetic resonance imaging study. Int J Cardiovasc Imaging. 2012 Aug;28(6):1435-44. doi: 10.1007/s10554-011-9949-4. Epub 2011 Oct 4.

  PMID: 21968545 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Adenosine; regadenoson

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Limitations and Caveats

Due to technical problems, data from two of the 30 subjects was not usable.

Results Point of Contact

• Title: Sheldon Litwin
• Organization: Univesity of Utah

sheldon.litwin@hsc.utah.edu

801-581-7715

Study Officials

• Sheldon E Litwin, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 10, 2009
• First Posted: March 11, 2009
• Study Start: February 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: May 24, 2011
• Results First Posted: May 24, 2011

Record last verified: 2011-05

Locations

US (1)