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Does Caffeine Affect the Sensitivity of Adenosine Perfusion Scans?

Primary Purpose

Coronary Artery Disease

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Cardiac SPECT imaging Rest and Stress

Caffeine

Caffeine

Sponsored by

University of Wisconsin, Madison

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring adenosine tracer scans, coronary artery disease, caffeine

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Caffeine 400 mg PO 1 hour before adenosine infusion

Caffeine 200 mg po one hour before adenosine infusion

Outcomes

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.

Secondary Outcome Measures

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

Full Information

NCT ID

First Posted

September 12, 2005

Last Updated

October 25, 2012

Sponsor

University of Wisconsin, Madison

Collaborators

Astellas Pharma US, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00205166

Brief Title

Does Caffeine Affect the Sensitivity of Adenosine Perfusion Scans?

Official Title

Does Caffeine Affect the Sensitivity of Adenosine Perfusion Scans?

Study Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Completed

Study Start Date

June 1999 (undefined)

Primary Completion Date

December 2004 (Actual)

Study Completion Date

December 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Wisconsin, Madison

Collaborators

Astellas Pharma US, Inc.

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

Keywords

adenosine tracer scans, coronary artery disease, caffeine

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1

Arm Type

Active Comparator

Arm Description

Caffeine 400 mg PO 1 hour before adenosine infusion

Arm Title

2

Arm Type

Active Comparator

Arm Description

Caffeine 200 mg po one hour before adenosine infusion

Intervention Type

Procedure

Intervention Name(s)

Cardiac SPECT imaging Rest and Stress

Intervention Description

adenosine perfusion scintigraphy

Intervention Type

Drug

Intervention Name(s)

Caffeine

Intervention Description

Caffeine 400 mg po

Intervention Type

Drug

Intervention Name(s)

Caffeine

Intervention Description

Caffeine 200 mg po

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

Time Frame

Assess at time of lab sample results obtained

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Charles K Stone, MD

Organizational Affiliation

Univeristy of Wisconsin

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Wisconsin

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53792

Country

United States

12. IPD Sharing Statement

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Does Caffeine Affect the Sensitivity of Adenosine Perfusion Scans?

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