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

Primary Purpose

Coronary Artery Disease (CAD)

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
regadenoson
overencapsulated caffeine
technetium
placebo
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease (CAD) focused on measuring pharmacologic stress, ischemia, coronary artery disease (CAD)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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
  • Subject has end stage renal disease (ESRD) with a GFR< 15mL/min or currently undergoing dialysis for ESRD

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo plus Regadenoson

Caffeine 200 mg plus Regadenoson

Caffeine 400 mg plus Regadenoson

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Change in Number of Reversible Defects
Each segment of the 17-Segment Model was assessed for radiotracer uptake on a scale of 0 (normal uptake) to 4 (absent uptake). Segments were counted as having a reversible defect if the stress score was greater than the rest score and the stress score was ≥ 2. Change was calculated as the number of reversible defects using regadenoson with caffeine/placebo (Day 5) minus the number of reversible defects using regadenoson alone (Day 3).

Secondary Outcome Measures

Change in Summed Difference Score (SDS) Across All 17 Segments
The Summed Difference Score was calculated as the difference in the Summed Stress Score across the 17 segments (scan run under stress condition) minus the Summed Rest Score across the 17 segments (scan run under rest conditions). Change in SDS was calculated as the SDS for regadenoson with caffeine/placebo stress scan (Day 5) minus the SDS for regadenoson only stress scan (Day 3). The full range of the SDS is -68 to 68, where 0 represents no change between Summed Stress Score and Summed Rest Score. A higher positive score indicates more severe coronary artery disease (CAD).
Change in Number of Reversible Defects Assessed by Computerized Quantitation
Each segment of the 17-Segment Model was assessed for radiotracer uptake on a scale of 0 (normal uptake) to 4 (absent uptake). Segments were counted as having a reversible defect if the stress score was greater than the rest score and the stress score was ≥ 2. Change was calculated as the number of reversible defects using regadenoson with caffeine/placebo (Day 5) minus the number of reversible defects using regadenoson alone (Day 3).
Change in Summed Difference Score Across All 17 Segments Assessed by Computerized Quantitation
The Summed Difference Score was calculated as the difference in the Summed Stress Score across the 17 segments (scan run under stress condition) minus the Summed Rest Score across the 17 segments (scan run under rest conditions). Change in SDS was calculated as the SDS for regadenoson with caffeine/placebo stress scan (Day 5) minus the SDS for regadenoson only stress scan (Day 3). The full range of the SDS is -68 to 68, where 0 represents no change between Summed Stress Score and Summed Rest Score. A higher positive score indicates more severe coronary artery disease (CAD).
Change From Baseline in Heart Rate
Baseline is the last non-missing measurement on or before first dose of regadenoson Change is calculated as the time point minus baseline.
Change From Baseline in Systolic Blood Pressure
Baseline is the last non-missing measurement on or before first dose of regadenoson. Change is calculated as the time point minus baseline.
Change From Baseline in Diastolic Blood Pressure
Baseline is the last non-missing measurement on or before first dose of regadenoson. Change is calculated as the time point minus baseline.

Full Information

First Posted
January 21, 2009
Last Updated
November 20, 2017
Sponsor
Astellas Pharma Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00826280
Brief Title
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

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
March 24, 2009 (Actual)
Primary Completion Date
July 15, 2010 (Actual)
Study Completion Date
July 15, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease (CAD)
Keywords
pharmacologic stress, ischemia, coronary artery disease (CAD)

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
347 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo plus Regadenoson
Arm Type
Placebo Comparator
Arm Description
Two placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
Arm Title
Caffeine 200 mg plus Regadenoson
Arm Type
Experimental
Arm Description
One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
Arm Title
Caffeine 400 mg plus Regadenoson
Arm Type
Experimental
Arm Description
Two 200 mg Caffeine capsules plus 0.4 mg regadenoson per 5mL intravenous bolus injection
Intervention Type
Drug
Intervention Name(s)
regadenoson
Other Intervention Name(s)
Lexiscan, CVT 3146
Intervention Description
IV
Intervention Type
Drug
Intervention Name(s)
overencapsulated caffeine
Intervention Description
oral
Intervention Type
Radiation
Intervention Name(s)
technetium
Other Intervention Name(s)
sestamibi, tetrafosmin
Intervention Description
IV
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
oral
Primary Outcome Measure Information:
Title
Change in Number of Reversible Defects
Description
Each segment of the 17-Segment Model was assessed for radiotracer uptake on a scale of 0 (normal uptake) to 4 (absent uptake). Segments were counted as having a reversible defect if the stress score was greater than the rest score and the stress score was ≥ 2. Change was calculated as the number of reversible defects using regadenoson with caffeine/placebo (Day 5) minus the number of reversible defects using regadenoson alone (Day 3).
Time Frame
Day 3 and Day 5
Secondary Outcome Measure Information:
Title
Change in Summed Difference Score (SDS) Across All 17 Segments
Description
The Summed Difference Score was calculated as the difference in the Summed Stress Score across the 17 segments (scan run under stress condition) minus the Summed Rest Score across the 17 segments (scan run under rest conditions). Change in SDS was calculated as the SDS for regadenoson with caffeine/placebo stress scan (Day 5) minus the SDS for regadenoson only stress scan (Day 3). The full range of the SDS is -68 to 68, where 0 represents no change between Summed Stress Score and Summed Rest Score. A higher positive score indicates more severe coronary artery disease (CAD).
Time Frame
Day 3 and Day 5
Title
Change in Number of Reversible Defects Assessed by Computerized Quantitation
Description
Each segment of the 17-Segment Model was assessed for radiotracer uptake on a scale of 0 (normal uptake) to 4 (absent uptake). Segments were counted as having a reversible defect if the stress score was greater than the rest score and the stress score was ≥ 2. Change was calculated as the number of reversible defects using regadenoson with caffeine/placebo (Day 5) minus the number of reversible defects using regadenoson alone (Day 3).
Time Frame
Day 3 and Day 5
Title
Change in Summed Difference Score Across All 17 Segments Assessed by Computerized Quantitation
Description
The Summed Difference Score was calculated as the difference in the Summed Stress Score across the 17 segments (scan run under stress condition) minus the Summed Rest Score across the 17 segments (scan run under rest conditions). Change in SDS was calculated as the SDS for regadenoson with caffeine/placebo stress scan (Day 5) minus the SDS for regadenoson only stress scan (Day 3). The full range of the SDS is -68 to 68, where 0 represents no change between Summed Stress Score and Summed Rest Score. A higher positive score indicates more severe coronary artery disease (CAD).
Time Frame
Day 3 and Day 5
Title
Change From Baseline in Heart Rate
Description
Baseline is the last non-missing measurement on or before first dose of regadenoson Change is calculated as the time point minus baseline.
Time Frame
Baseline, Day 5 (-3 min), Day 5 (+3 min), Day 5 (+15 min)
Title
Change From Baseline in Systolic Blood Pressure
Description
Baseline is the last non-missing measurement on or before first dose of regadenoson. Change is calculated as the time point minus baseline.
Time Frame
Baseline, Day 5 (-3 min), Day 5 (+3 min), Day 5 (+15 min)
Title
Change From Baseline in Diastolic Blood Pressure
Description
Baseline is the last non-missing measurement on or before first dose of regadenoson. Change is calculated as the time point minus baseline.
Time Frame
Baseline, Day 5 (-3 min), Day 5 (+3 min), Day 5 (+15 min)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Organizational Affiliation
Astellas Pharma Global Development
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95405
Country
United States
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102-5037
Country
United States
City
Newark
State/Province
Delaware
ZIP/Postal Code
19173
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
City
Aurora
State/Province
Illinois
ZIP/Postal Code
60504
Country
United States
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66209
Country
United States
City
Auburn
State/Province
Maine
ZIP/Postal Code
04210
Country
United States
City
Pittsfield
State/Province
Massachusetts
ZIP/Postal Code
01201
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
City
Albany
State/Province
New York
ZIP/Postal Code
12205
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14642-8679
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Details of the IPD sharing plan for this study can be found at www.clinicalstudydatarequest.com.
Citations:
PubMed Identifier
21082298
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.
Results Reference
derived
Links:
URL
https://www.astellasclinicalstudyresults.com/study.aspx?ID=49
Description
Link to results on Astellas Clinical Study Results website

Learn more about this trial

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

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