Does Caffeine Affect the Sensitivity of Adenosine Perfusion Scans?
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cardiac SPECT imaging Rest and Stress
Caffeine
Caffeine
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring adenosine tracer scans, coronary artery disease, caffeine
Eligibility Criteria
Inclusion Criteria: Patients who have already completed rest/stress 99mTc sestamibi or 99mTc tetrofosmin imaging will be given a form describing this protocol and asked to volunteer for the additional scan Exclusion Criteria: history of asthma, bronchospastic COPD, or renal failure
Sites / Locations
- University of Wisconsin
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Caffeine 400 mg PO 1 hour before adenosine infusion
Caffeine 200 mg po one hour before adenosine infusion
Outcomes
Primary Outcome Measures
This protocol has a specific aim of determining whether prior caffeine administration affects the sensitivity and specificity of adenosine perfusion scintigraphy for detection of impaired coronary vascular reserve.
Secondary Outcome Measures
determination of caffeine levels in patients instructed to hold caffeine prior to adenosine imaging
Full Information
NCT ID
NCT00205166
First Posted
September 12, 2005
Last Updated
October 25, 2012
Sponsor
University of Wisconsin, Madison
Collaborators
Astellas Pharma US, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00205166
Brief Title
Does Caffeine Affect the Sensitivity of Adenosine Perfusion Scans?
Official Title
Does Caffeine Affect the Sensitivity of Adenosine Perfusion Scans?
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
June 1999 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
December 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
Astellas Pharma US, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
We are studying the affect of caffeine on the sensitivity of detecting coronary artery disease (blockages in the blood flow to the heart) with adenosine tracer scans. Adenosine is a drug used routinely in patients to relax heart blood vessels in order to assess for the presence of coronary artery disease. Often, if patients have had caffeine, the adenosine scan is not used because of the belief that caffeine may reduce the ability to detect coronary artery disease. We would like to test whether caffeine affects our ability to detect coronary artery disease with adenosine tracer scanning. We will perform an imaging study of the heart with adenosine after you have received caffeine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
adenosine tracer scans, coronary artery disease, caffeine
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Caffeine 400 mg PO 1 hour before adenosine infusion
Arm Title
2
Arm Type
Active Comparator
Arm Description
Caffeine 200 mg po one hour before adenosine infusion
Intervention Type
Procedure
Intervention Name(s)
Cardiac SPECT imaging Rest and Stress
Intervention Description
adenosine perfusion scintigraphy
Intervention Type
Drug
Intervention Name(s)
Caffeine
Intervention Description
Caffeine 400 mg po
Intervention Type
Drug
Intervention Name(s)
Caffeine
Intervention Description
Caffeine 200 mg po
Primary Outcome Measure Information:
Title
This protocol has a specific aim of determining whether prior caffeine administration affects the sensitivity and specificity of adenosine perfusion scintigraphy for detection of impaired coronary vascular reserve.
Time Frame
Assessment is made at the time of research adenosine perfusion scintigraphy
Secondary Outcome Measure Information:
Title
determination of caffeine levels in patients instructed to hold caffeine prior to adenosine imaging
Time Frame
Assess at time of lab sample results obtained
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who have already completed rest/stress 99mTc sestamibi or 99mTc tetrofosmin imaging will be given a form describing this protocol and asked to volunteer for the additional scan
Exclusion Criteria:
history of asthma, bronchospastic COPD, or renal failure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles K Stone, MD
Organizational Affiliation
Univeristy of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
12. IPD Sharing Statement
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Does Caffeine Affect the Sensitivity of Adenosine Perfusion Scans?
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