Expired Study
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Madison, Wisconsin 53792


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.


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


Study is Available At:


Original ID:

1999-109


NCT ID:

NCT00205166


Secondary ID:


Study Acronym:


Brief Title:

Does Caffeine Affect the Sensitivity of Adenosine Perfusion Scans?


Official Title:

Does Caffeine Affect the Sensitivity of Adenosine Perfusion Scans?


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

80 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Wisconsin, Madison


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Para


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

50


Enrollment Type:

Actual


Overall Contact Information

Official Name:Charles K Stone, MD
Principal Investigator
Univeristy of Wisconsin

Study Dates

Start Date:June 1999
Completion Date:December 2008
Completion Type:Actual
Primary Completion Date:December 2008
Primary Completion Type:Actual
Verification Date:August 2012
Last Changed Date:August 28, 2012
First Received Date:September 12, 2005

Study Outcomes

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

Study Interventions

Intervention Type:Procedure
Name:Cardiac SPECT imaging Rest and Stress
Description:adenosine perfusion scintigraphy
Arm Name:1
Intervention Type:Drug
Name:Caffeine
Description:Caffeine 400 mg po
Arm Name:1
Intervention Type:Drug
Name:Caffeine
Description:Caffeine 200 mg po
Arm Name:2

Study Arms

Study Arm Type:Active Comparator
Arm Name:2
Description:Caffeine 200 mg po one hour before adenosine infusion
Study Arm Type:Active Comparator
Arm Name:1
Description:Caffeine 400 mg PO 1 hour before adenosine infusion

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Wisconsin, Madison
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Astellas Pharma US, Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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