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Caffeine's Effect on Regadenoson Administration With Single Photon Emission Computed Tomography (SPECT) Myocardial Perfusion Imaging (MPI) | Clinical Trials | Clareo Health

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Caffeine's Effect on Regadenoson Administration With Single Photon Emission Computed Tomography (SPECT) Myocardial Perfusion Imaging (MPI)

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

NCT00826280•Astellas Pharma Inc

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+1 more criteria

Locations (25)

Birmingham, Alabama, United States

Huntsville, Alabama, United States

La Mesa, California, United States

Mission Viejo, California, United States

Roseville, California, United States

Sacramento, California, United States

Santa Rosa, California, United States

Hartford, Connecticut, United States

Newark, Delaware, United States

Jacksonville, Florida, United States

Key Dates

Start Date

March 24, 2009

Primary Completion Date

July 15, 2010

Completion Date

July 15, 2010

Last Updated

December 3, 2024

Enrollment

347

ACTUAL participants

Conditions

Coronary Artery Disease (CAD)

Interventions

regadenoson

DRUG

overencapsulated caffeine

DRUG

technetium

RADIATION

placebo

DRUG

"Erectile Function After PCI in MI and Non-MI Patients"

NCT07444697

Erectile DisfunctionCoronary Artery Disease (CAD)+3 more

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RECRUITING

Dedinje FFR/QFR Registry

NCT06659367

Coronary Artery Disease (CAD)Fractional Flow Reserve

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 3, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Caffeine's Effect on Regadenoson Administration With Single Photon Emission Computed Tomography (SPECT) Myocardial Perfusion Imaging (MPI)

Inclusion Criteria

Exclusion Criteria

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