Does Caffeine Affect the Sensitivity of Adenosine Perfusion Scans?

October 25, 2012 updated by: University of Wisconsin, Madison
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
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
Drug: Caffeine
Caffeine 200 mg po
Active Comparator: 2
Caffeine 200 mg po one hour before adenosine infusion
Procedure: Cardiac SPECT imaging Rest and Stress
adenosine perfusion scintigraphy
Drug: Caffeine
Caffeine 400 mg po
Drug: Caffeine
Caffeine 200 mg po

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Assessment is made at the time of research adenosine perfusion scintigraphy

Secondary Outcome Measures

Outcome Measure
Time Frame
determination of caffeine levels in patients instructed to hold caffeine prior to adenosine imaging
Time Frame: Assess at time of lab sample results obtained
Assess at time of lab sample results obtained

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Collaborators

Astellas Pharma US, Inc.

Investigators

  • Principal Investigator: Charles K Stone, MD, Univeristy of Wisconsin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 1999

Primary Completion (Actual)

December 1, 2004

Study Completion (Actual)

December 1, 2004

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

October 29, 2012

Last Update Submitted That Met QC Criteria

October 25, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1999-109

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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