Coronary Artery DiseaseNCT00205166
Does Caffeine Affect the Sensitivity of Adenosine Perfusion Scans?
A study testing Cardiac SPECT imaging Rest and Stress and Caffeine in people with Coronary Artery Disease, run by University of Wisconsin, Madison at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Cardiac SPECT imaging Rest and Stress and Caffeine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 1999to Dec 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- history of asthma, bronchospastic COPD, or renal failure
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Cardiac SPECT imaging Rest and Stress, Caffeine
- Keywords
- adenosine tracer scans, coronary artery disease, caffeine
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac SPECT imaging Rest and StressProcedure or surgery
adenosine perfusion scintigraphy
CaffeineDrug
Caffeine 400 mg po
CaffeineDrug
Caffeine 200 mg po
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Caffeine 400 mg PO 1 hour before adenosine infusion Receives: Procedure: Cardiac SPECT imaging Rest and Stress; Drug: Caffeine |
| 2 | Active comparator | Caffeine 200 mg po one hour before adenosine infusion Receives: Procedure: Cardiac SPECT imaging Rest and Stress; Drug: Caffeine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Assess at time of lab sample results obtained
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJun 1999
- Primary completionDec 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma US, Inc.
- Responsible party
- Sponsor
- Investigators
- Charles K Stone, MD, Principal investigator, Univeristy of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00205166
- Sponsor's protocol ID
- 1999-109
- Status last verified
- Oct 2012
- First submitted
- 12 Sep 2005
- Last updated
- 29 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Caffeine Affect the Sensitivity of Adenosine Perfusion Scans?
- ClinicalTrials.gov ID
- NCT00205166
- Acronym / sponsor ID
- 1999-109
- Conditions
- Coronary Artery Disease
- Keywords
- adenosine tracer scans, coronary artery disease, caffeine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Astellas Pharma US, Inc.
- Study start
- Jun 1999
- Primary completion
- Dec 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Cardiac SPECT imaging Rest and Stress, Drug: CaffeineCaffeine 400 mg PO 1 hour before adenosine infusion |
| 2 | Active comparator | Procedure: Cardiac SPECT imaging Rest and Stress, Drug: CaffeineCaffeine 200 mg po one hour before adenosine infusion |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- history of asthma, bronchospastic COPD, or renal failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac SPECT imaging Rest and Stressadenosine perfusion scintigraphy | Procedure or surgery | 1, 2 |
| CaffeineCaffeine 400 mg po | Drug | 1 |
| CaffeineCaffeine 200 mg po | Drug | 2 |
Primary outcome
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
1 secondary outcome
determination of caffeine levels in patients instructed to hold caffeine prior to adenosine imaging
Time frame: Assess at time of lab sample results obtained
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles K Stone, MD principal investigator
Univeristy of Wisconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac SPECT imaging Rest and Stress and Caffeine in people with Coronary Artery Disease, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2012.