Does Caffeine Affect the Sensitivity of Adenosine Perfusion Scans?

NCT00205166 | Completed

• 1 other identifier: 1999-109
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease

Keywords

adenosine tracer scans; coronary artery disease; caffeine

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• determination of caffeine levels in patients instructed to hold caffeine prior to adenosine imaging

  Assess at time of lab sample results obtained

Study Arms (2)

1

ACTIVE COMPARATOR

Caffeine 400 mg PO 1 hour before adenosine infusion

Procedure: Cardiac SPECT imaging Rest and Stress; Drug: Caffeine

2

ACTIVE COMPARATOR

Caffeine 200 mg po one hour before adenosine infusion

Procedure: Cardiac SPECT imaging Rest and Stress; Drug: Caffeine

Interventions

Cardiac SPECT imaging Rest and Stress PROCEDURE

adenosine perfusion scintigraphy

1; 2

Caffeine DRUG

Caffeine 400 mg po

1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• history of asthma, bronchospastic COPD, or renal failure

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Astellas Pharma US, Inc.: collaborator

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Caffeine

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Charles K Stone, MD

  Univeristy of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: June 1, 1999
• Primary Completion: December 1, 2004
• Study Completion: December 1, 2004
• Last Updated: October 29, 2012

Record last verified: 2012-10

Locations

US (1)