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Astellas Study ID
3606-CL-3002

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

Astellas Study ID
3606-CL-3002
Clinicaltrials.gov ID
NCT00826280
EUCTIS ID
N/A
EudraCT ID
N/A
jRCT ID
N/A
CN CDE ID
N/A
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Study 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

Additional Study Details

Phase
3
Product
N/A
Product
regadenoson
overencapsulated caffeine
placebo
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment number
347
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Study documents

Scientific Results Summary
Available Language(s): English
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Plain Language Summary
Available Language(s): English
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Would you like more information about clinical trial sites that are recruiting participants for Caffeine's Effect on Regadenoson administration with Single Photon Emission Computed Tomography (SPECT) Myocardial Perfusion Imaging (MPI)? Contact us by filling out your information to the right and we’ll respond to you.

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    Locations

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    Terminated
    Knoxville, TN, United States, 37920
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    Terminated
    Albany, New York, United States, 12205
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    Aurora, Illinois, United States, 60504
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    Completed
    Rochester, NY, United States, 14642-8679
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    Completed
    Miami, FL, United States, 33173
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    Boston, MA, United States, 02114
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    Wyomissing, PA, United States, 19610
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    Mission Viejo, CA, United States, 92691
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    Completed
    Overland Park, KS, United States, 66209
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    La Mesa, CA, United States, 91942
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    Terminated
    Kansas City, MO, United States, 64111
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    Completed
    Detroit, MI, United States, 48202
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    Boston, MA, United States, 02115
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    Durham, NC, United States, 27710
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    Philadelphia, PA, United States, 19140
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    Santa Rosa, CA, United States, 95405
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    Sacramento, CA, United States, 95819
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    Jacksonville, FL, United States, 32216
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    Ypsilanti, MI, United States, 48197
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    New Haven, CT, United States, 06504
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    Hartford, CT, United States, 06102-5037
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    Newark, DE, United States, 19173
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    Birmingham, Alabama, United States, 35294
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    Denver, CO, United States, 80204
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    Columbus, OH, United States, 43214
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    Pittsfield, MA, United States, 01201
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    Winfield, IL, United States, 60190
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    Tamarac, FL, United States, 33321
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    Roseville, CA, United States, 95661
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    Auburn, ME, United States, 04210
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    Philadelphia, PA, United States, 19102
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    San Diego, CA, United States, 92161
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    Huntsville, AL, United States, 35801
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    Withdrawn
    Manhasset, NY, United States, 11030
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    Trial info
    Follow Trial
    Age
    18+ years
    Diamond icon
    Condition
  • Heart Disease
    • Gender icon
    Sex
    Female & Male
    Calendar icon
    Trial Dates
    Mar 2009 - Jul 2010
    Additional Study Details
    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
    MaximizeExclusion 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

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