Clinical trial NCT00826280: Caffeine's Effect on Regadenoson Administration With Single Photon Emission Computed Tomography (SPECT) Myocardial Perfusion Imaging (MPI)
Official title: A Phase 3b, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Caffeine Intake on Single Photon Emission Computed Tomography (SPECT) Myocardial Perfusion Imaging (MPI) in Subjects Administered Regadenoson
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Artery Disease (CAD)
Keywords: pharmacologic stress
ischemia
coronary artery disease (CAD)
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2009-01-22
Enrollment: 347
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Observe whether the administration of caffeine prior to regadenoson will affect the interpretation of test results in subjects with coronary artery disease (CAD) undergoing SPECT MPI

Detailed description: All subjects will undergo rest and stress scans. Those subjects who qualify by demonstrating at least 1 reversible defect, will undergo a third scan. All stress scans will involve the injection of regadenoson as the pharmacologic stress agent. Prior to the third scan, the subject will be administered blinded capsules of placebo or caffeine.

Eligibility criteria: Inclusion Criteria:

* Subject must have undergone a previous diagnostic study \[e.g., SPECT, echocardiography, magnetic resonance imaging (MRI), etc.\] for a clinical indication demonstrating evidence of reversible defects in ≥ 1 vascular segment, have had other stress testing within the past 3 months, or the subject's history suggests at least a 50% likelihood of CAD

  * If the previous diagnostic study shows only 1 reversible defect and it is in segment 17, another reversible defect will need to be present
* Subject with CAD must have an intermediate/low-risk for immediate intervention
* Subject must ingest caffeinated food or beverages regularly (at least the equivalent of one cup of caffeinated coffee daily)
* Subject must agree to not ingest any caffeine or other foods containing methylxanthine at least 24 hours prior to each study visit
* Subject must agree to abstain from eating solid food or drinking liquids other than water for at least 30 minutes prior to each study visit and 30 minutes following each study visit

Exclusion Criteria:

* Subject with documented myocardial infarction (MI) ≤ 30 days prior to enrollment
* Subject with history of percutaneous coronary intervention (PCI) ≤ 4 weeks prior to enrollment
* Subject with history of coronary artery bypass graft (CABG) ≤ 8 weeks prior to enrollment
* Subject has prior history of heart transplantation
* Subject has unstable angina, known severe left main coronary artery stenosis, severe heart failure, uncontrolled arrhythmias, symptomatic hypotension or severe hypertension (systolic blood pressure \< 90 or \> 180 mmHg, respectively), or \> 1st degree atrioventricular block in the absence of a functioning pacemaker
* Subject requires emergent cardiac medical intervention or catheterization
* Subject has a history of smoking, regardless of frequency, tobacco type or method of intake, or using any smoking cessation products, including but not limited to the nicotine patch or nicotine gum, within 3 months prior to first dose of regadenoson
* Subject is currently undergoing treatment with theophylline, or theophylline containing medications within 7 days prior to randomization (Day 3)
* Subject has a history of known or suspected bronchoconstrictive or bronchospastic lung disease \[e.g., asthma, wheezing, chronic obstructive pulmonary disease (COPD), etc.\]
* Subject has a history of diabetes associated with gastric disorders and/or emptying
* Subject has end stage renal disease (ESRD) with a GFR\< 15mL/min or currently undergoing dialysis for ESRD

Primary outcomes:
measure: Change in Number of Reversible Defects
timeFrame: Day 3 and Day 5
Secondary outcomes:
measure: Change in Summed Difference Score (SDS) Across All 17 Segments
timeFrame: Day 3 and Day 5
measure: Change in Number of Reversible Defects Assessed by Computerized Quantitation
timeFrame: Day 3 and Day 5
measure: Change in Summed Difference Score Across All 17 Segments Assessed by Computerized Quantitation
timeFrame: Day 3 and Day 5
measure: Change From Baseline in Heart Rate
timeFrame: Baseline, Day 5 (-3 min), Day 5 (+3 min), Day 5 (+15 min)
measure: Change From Baseline in Systolic Blood Pressure
timeFrame: Baseline, Day 5 (-3 min), Day 5 (+3 min), Day 5 (+15 min)
measure: Change From Baseline in Diastolic Blood Pressure
timeFrame: Baseline, Day 5 (-3 min), Day 5 (+3 min), Day 5 (+15 min)
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Huntsville
country: United States
state: Alabama
city: La Mesa
country: United States
state: California
city: Mission Viejo
country: United States
state: California
city: Roseville
country: United States
state: California
city: Sacramento
country: United States
state: California
city: Santa Rosa
country: United States
state: California
city: Hartford
country: United States
state: Connecticut
city: Newark
country: United States
state: Delaware
city: Jacksonville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Tamarac
country: United States
state: Florida
city: Aurora
country: United States
state: Illinois
city: Overland Park
country: United States
state: Kansas
city: Auburn
country: United States
state: Maine
city: Pittsfield
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: Ypsilanti
country: United States
state: Michigan
city: Kansas City
country: United States
state: Missouri
city: Albany
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Columbus
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Wyomissing
country: United States
state: Pennsylvania
city: Knoxville
country: United States
state: Tennessee
Study officials:
affiliation: Astellas Pharma Global Development
name: Use Central Contact
role: STUDY_DIRECTOR
References:
citation: Tejani FH, Thompson RC, Iskandrian AE, McNutt BE, Franks B. Effect of caffeine on SPECT myocardial perfusion imaging during regadenoson pharmacologic stress: rationale and design of a prospective, randomized, multicenter study. J Nucl Cardiol. 2011 Feb;18(1):73-81. doi: 10.1007/s12350-010-9311-6. Epub 2010 Nov 17.