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Trial record 31 of 1205 for:    adenosine

Does Caffeine Affect the Sensitivity of Adenosine Perfusion Scans?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00205166
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : October 29, 2012
Sponsor:
Collaborator:
Astellas Pharma US, Inc.
Information provided by (Responsible Party):
University of Wisconsin, Madison

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 20, 2005
Last Update Posted Date October 29, 2012
Study Start Date  ICMJE June 1999
Actual Primary Completion Date December 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2007)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
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.
Change History Complete list of historical versions of study NCT00205166 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2007)
determination of caffeine levels in patients instructed to hold caffeine prior to adenosine imaging [ Time Frame: Assess at time of lab sample results obtained ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
determination of caffeine levels in patinets instructed to hol caffiene prior to adenosine imaging
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Does Caffeine Affect the Sensitivity of Adenosine Perfusion Scans?
Official Title  ICMJE Does Caffeine Affect the Sensitivity of Adenosine Perfusion Scans?
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE
  • Procedure: Cardiac SPECT imaging Rest and Stress
    adenosine perfusion scintigraphy
  • Drug: Caffeine
    Caffeine 400 mg po
  • Drug: Caffeine
    Caffeine 200 mg po
Study Arms  ICMJE
  • Active Comparator: 1
    Caffeine 400 mg PO 1 hour before adenosine infusion
    Interventions:
    • Procedure: Cardiac SPECT imaging Rest and Stress
    • Drug: Caffeine
  • Active Comparator: 2
    Caffeine 200 mg po one hour before adenosine infusion
    Interventions:
    • Procedure: Cardiac SPECT imaging Rest and Stress
    • Drug: Caffeine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 13, 2005)
50
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2004
Actual Primary Completion Date December 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00205166
Other Study ID Numbers  ICMJE 1999-109
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Wisconsin, Madison
Study Sponsor  ICMJE University of Wisconsin, Madison
Collaborators  ICMJE Astellas Pharma US, Inc.
Investigators  ICMJE
Principal Investigator: Charles K Stone, MD Univeristy of Wisconsin
PRS Account University of Wisconsin, Madison
Verification Date October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP