Does Caffeine Affect the Sensitivity of Adenosine Perfusion Scans?

Coronary Artery Disease Clinical Trial

Official title:

Does Caffeine Affect the Sensitivity of Adenosine Perfusion Scans?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00205166
• Other study ID #: 1999-109
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: October 25, 2012
• Start date: June 1999
• Est. completion date: December 2004

Study information

• Verified date: October 2012
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2004
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• Cardiac SPECT imaging Rest and Stress
adenosine perfusion scintigraphy

Drug:
• Caffeine
Caffeine 400 mg po
• Caffeine
Caffeine 200 mg po

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Astellas Pharma US, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Assessment is made at the time of research adenosine perfusion scintigraphy	No
Secondary	determination of caffeine levels in patients instructed to hold caffeine prior to adenosine imaging		Assess at time of lab sample results obtained	No