Does Caffeine Affect the Sensitivity of Adenosine Perfusion Scans? - Full Text View

Sponsor:	University of Wisconsin, Madison
Collaborator:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Caffeine Coronary Artery Disease Nuclear Scans

Drug Information available for: 3,7-Dihydro-1,3,7-trimethyl-1H-purine-2,6-dione Adenosine Caffeine citrate

U.S. FDA Resources

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

No publications provided

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

Keywords provided by University of Wisconsin, Madison:

adenosine tracer scans
coronary artery disease
caffeine

Additional relevant MeSH terms:

Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Myocardial Ischemia
Physiological Effects of Drugs
Arteriosclerosis
Sensory System Agents
Therapeutic Uses
Caffeine
Cardiovascular Diseases
Analgesics
Anti-Arrhythmia Agents
Caffeine citrate
Arterial Occlusive Diseases

Heart Diseases
Vascular Diseases
Enzyme Inhibitors
Central Nervous System Stimulants
Cardiovascular Agents
Pharmacologic Actions
Coronary Disease
Phosphodiesterase Inhibitors
Peripheral Nervous System Agents
Adenosine
Central Nervous System Agents
Coronary Artery Disease

ClinicalTrials.gov processed this record on February 04, 2010