CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
Adenosine +1 moredrug
Likely dose
Regadenoson 0.4 mg/5 mL bolus (single dose) or adenosine 0.14 mg/kg/min × 6 minutes infusionAI-extracted
Key inclusion· 2
  • Age 18–88 years
  • BMI 20–40 kg/m²
Key exclusion· 6
  • Critically ill patients, patients on ventilators, or patients with hypotension whose safety may be compromised
  • Asthma or other condition where medical care/safety compromised by MRI
  • Claustrophobia
  • MRI contraindications: pacemaker, ICD, or metal implants

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00859833
NCT00859833N/ACompleted

Effects of Body Mass Index on the Hyperemic Response to Regadenoson

University of Utah·interventional·Posted Mar 11, 2009·Updated May 24, 2011

In Brief

A clinical study evaluating Adenosine and Regadenoson for Obesity and 2 related conditions. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsAstellas Pharma Inc

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 11, 2009
Enrollment StartFeb 1, 2009
Primary CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 17.3 years ago

Interventions

Adenosinedrug

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

Regadenosondrug

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