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

NCT ID: NCT00826280

Last Updated: 2024-12-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

347 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-24

Study Completion Date

2010-07-15

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease (CAD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo plus Regadenoson

Two placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection

Group Type PLACEBO_COMPARATOR

regadenoson

Intervention Type DRUG

IV

technetium

Intervention Type RADIATION

IV

placebo

Intervention Type DRUG

oral

Caffeine 200 mg plus Regadenoson

One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection

Group Type EXPERIMENTAL

regadenoson

Intervention Type DRUG

IV

overencapsulated caffeine

Intervention Type DRUG

oral

technetium

Intervention Type RADIATION

IV

Caffeine 400 mg plus Regadenoson

Two 200 mg Caffeine capsules plus 0.4 mg regadenoson per 5mL intravenous bolus injection

Group Type EXPERIMENTAL

regadenoson

Intervention Type DRUG

IV

overencapsulated caffeine

Intervention Type DRUG

oral

technetium

Intervention Type RADIATION

IV

Interventions

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regadenoson

IV

Intervention Type DRUG

overencapsulated caffeine

oral

Intervention Type DRUG

technetium

IV

Intervention Type RADIATION

placebo

oral

Intervention Type DRUG

Other Intervention Names

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Lexiscan CVT 3146 sestamibi tetrafosmin

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Use Central Contact

Role: STUDY_DIRECTOR

Astellas Pharma Global Development

Locations

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Birmingham, Alabama, United States

Site Status

Huntsville, Alabama, United States

Site Status

La Mesa, California, United States

Site Status

Mission Viejo, California, United States

Site Status

Roseville, California, United States

Site Status

Sacramento, California, United States

Site Status

Santa Rosa, California, United States

Site Status

Hartford, Connecticut, United States

Site Status

Newark, Delaware, United States

Site Status

Jacksonville, Florida, United States

Site Status

Miami, Florida, United States

Site Status

Tamarac, Florida, United States

Site Status

Aurora, Illinois, United States

Site Status

Overland Park, Kansas, United States

Site Status

Auburn, Maine, United States

Site Status

Pittsfield, Massachusetts, United States

Site Status

Detroit, Michigan, United States

Site Status

Ypsilanti, Michigan, United States

Site Status

Kansas City, Missouri, United States

Site Status

Albany, New York, United States

Site Status

Rochester, New York, United States

Site Status

Columbus, Ohio, United States

Site Status

Philadelphia, Pennsylvania, United States

Site Status

Wyomissing, Pennsylvania, United States

Site Status

Knoxville, Tennessee, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 21082298 (View on PubMed)

Related Links

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https://www.astellasclinicalstudyresults.com/study.aspx?ID=49

Link to results on Astellas Clinical Study Results website

Other Identifiers

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3606-CL-3002

Identifier Type: -

Identifier Source: org_study_id