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Does Caffeine Affect the Sensitivity of Adenosine Perfusion Scans?

This study has been suspended.

Sponsors and Collaborators: University of Wisconsin, Madison
Astellas Pharma US, Inc.
Information provided by: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00205166
  Purpose

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.


Condition Intervention
Coronary Artery Disease
Procedure: Cardiac SPECT imaging Rest and Stress
Drug: Caffeine

MedlinePlus related topics:   Caffeine    Coronary Artery Disease    Nuclear Scans   

ChemIDplus related topics:   Adenosine    3,7-Dihydro-1,3,7-trimethyl-1H-purine-2,6-dione    Caffeine citrate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Diagnostic, Randomized, Open Label, Active Control, Parallel Assignment
Official Title:   Does Caffeine Affect the Sensitivity of Adenosine Perfusion Scans?

Further study details as provided by University of Wisconsin, Madison:

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. [ Time Frame: Assessment is made at the time of research adenosine perfusion scintigraphy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • determination of caffeine levels in patients instructed to hold caffeine prior to adenosine imaging [ Time Frame: Assess at time of lab sample results obtained ] [ Designated as safety issue: No ]

Estimated Enrollment:   50
Study Start Date:   June 1999
Estimated Study Completion Date:   December 2008
Estimated Primary Completion Date:   December 2008 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Active Comparator
Caffeine 400 mg PO 1 hour before adenosine infusion
Procedure: Cardiac SPECT imaging Rest and Stress
adenosine perfusion scintigraphy
Drug: Caffeine
Caffeine 400 mg po
2: Active Comparator
Caffeine 200 mg po one hour before adenosine infusion
Procedure: Cardiac SPECT imaging Rest and Stress
adenosine perfusion scintigraphy
Drug: Caffeine
Caffeine 200 mg po

  Eligibility
Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Patients who have already completed rest/stress 99mTc sestamibi or 99mTc tetrafosmin 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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00205166

Locations
United States, Wisconsin
University of Wisconsin    
      Madison, Wisconsin, United States, 53792

Sponsors and Collaborators
University of Wisconsin, Madison
Astellas Pharma US, Inc.

Investigators
Principal Investigator:     Charles K Stone, MD     Univeristy of Wisconsin    
  More Information


Responsible Party:   University of Wisconsin ( Charles K. Stone, MD )
Study ID Numbers:   1999-109
First Received:   September 12, 2005
Last Updated:   May 16, 2008
ClinicalTrials.gov Identifier:   NCT00205166
Health Authority:   United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
adenosine tracer scans  
coronary artery disease  
caffeine  

Study placed in the following topic categories:
Caffeine citrate
Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Citric Acid
Vascular Diseases
Caffeine
Arteriosclerosis
Ischemia
Adenosine
Coronary Artery Disease

Additional relevant MeSH terms:
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Central Nervous System Stimulants
Enzyme Inhibitors
Cardiovascular Agents
Pharmacologic Actions
Phosphodiesterase Inhibitors
Sensory System Agents
Therapeutic Uses
Cardiovascular Diseases
Analgesics
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 10, 2008




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