Coronary Artery DiseaseNCT00892307
Adenosine Dual Source Computed Tomography (CT) Versus Adenosine Single Photon Emission Computed Tomography (SPECT)
An observational study of Coronary Artery Disease, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
Researchers hope that this new non-invasive multi-detector scanner (DSCT) will provide diagnostic information comparable to the combination of traditional SPECT (for function and blood flow) and CT imaging (for a precise anatomical view). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Dual Source Multidetector CT (DSCT) w/ Adenosine enhancement
- Type of treatment
- Surgery or procedure
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to May 2011
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Coronary Artery Disease
Who may be able to join
- Provide written consent and are willing to comply with protocol requirements
- Are at least 18 years of age
- Are referred for clinically-ordered SPECT
- Have known CAD
- Have had prior (within 30 days) positive Adeno-SPECT scan
Who cannot join
- Patients being referred to invasive coronary angiography will not be included in this pilot
- Caffeine intake within the 24 hours prior to adenosine stress testing
- Pregnancy (known or suspected)
- Intolerance or contraindication to adenosine (severe Asthma…)
- Intake of methylxanthine containing medications such as theophylline that have not been withdrawn and would interfere with the effectiveness of adenosine.
- Unstable coronary syndromes
Show all 24Show fewer
- Uncontrolled congestive cardiac failure or cardiogenic shock
- Uncontrolled hypertension with resting BP > 200/110
- More than 30 days between the Adeno-SPECT and the Adeno-DSCT
- Revascularization (percutaneous coronary intervention or coronary artery bypass graft surgery) between the Adeno-SPECT and the Adeno-DSCT
- Change in clinical status as determined by the investigator
- Inability to be on same medication regime 24 hrs prior to Adeno-SPECT and Adeno DSCT
- Patients with chronic renal failure (C.C.T. < 60 ml/m2/sec)
- Patients with allergy to contrast iodinated media
- Congestive heart failure
- History of thromboembolic disorders
- Multiple myeloma
- Hyperthyroidism
- Pheochromocytoma
- Atrial fibrillation
- Inability to perform breath hold for 12 seconds
- Pilot 2:
- All inclusions/exclusions are the same as Pilot 1, WITH THE ADDITION OF:
- Patients with contraindications to coronary angiography
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: Coronary Anatomy and Physiology Using Multidetector Dual Source Computed Tomography With Adenosine Enhancement: Comparative Study With SPECT Imaging: Pilot Studies I/II
Researchers hope that this new non-invasive multi-detector scanner (DSCT) will provide diagnostic information comparable to the combination of traditional SPECT (for function and blood flow) and CT imaging (for a precise anatomical view).
Read the detailed description
The DSCT scanner is able to assess cardiac blood flow (myocardial perfusion) at the same time as coronary anatomy. The results derived from these scans will be compared to standard SPECT imaging.
To further evaluate obstruction in the coronary arteries, physicians may refer for an invasive Coronary Angiogram, the current gold standard for diagnosis of Coronary Artery Disease (CAD). By validating the DSCT scanner as a system with which to assess the extent of obstruction in the coronary arteries, physicians may be able to lessen the occurrence of an invasive exam.
Procedures: Each pilot anticipates enrolling 20 subjects.
Pilot 1: Clinical Follow-up Rest/Stress Adeno-SPECT and Research Stress /Rest Adeno-DSCT obtained in the same patient during the same period of stress testing
- Radiation: Thallium injection for rest SPECT
- Drug: Single dose Adenosine Infusion for DSCT and SPECT
- Radiation: Sestamibi injection for stress SPECT
- Drug: CT contrast
- Radiation: Stress DSCT /Rest DSCT
Pilot 2: Research Stress/ Rest Adeno-DSCT obtained within 30 days of initial positive SPECT finding
- Drug: Adenosine Infusion for DSCT
- Drug: CT contrast
- Radiation: Stress DSCT /Rest DSCT
Both pilot studies will relate results to subject history, ECG and cardiac angiogram, if available
- Conditions
- Coronary Artery Disease
- Being tested
- Dual Source Multidetector CT (DSCT) w/ Adenosine enhancement
- Keywords
- Diagnostic Imaging, Dual Source Multidetector Computed Tomography, Computed Tomography, CT, Single Photon Emission Computed Tomography, SPECT, Myocardial Perfusion, Atherosclerosis
- Medical subject headings
- Coronary Artery Disease, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual Source Multidetector CT (DSCT) w/ Adenosine enhancementRadiation
Also called Dual Source Multidetector Computed Tomography, Dual Source CT, Dual Source CT with adenosine enhancement, Adenosine enhanced CT
Somatom Definition Dual Source CT Scanner Stress/Rest Image scan using weight based CT contrast dye
What is being measured
The primary outcome is the main question the study is designed to answer.
To show that adenosine enhanced DSCT will enhance regular Multidetector Spiral Computed Tomography (MSCT) "diagnostic power" to detect significant (e.g., > 50%) coronary stenosis
Measured: One day
Secondary outcomes (1)
To assess coronary anatomical results obtained by CT Angiography (CTA) at high heart rates in terms of the rate of assessable coronary segments.
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2009 (estimated)
- Study startFeb 2007
- Primary completionFeb 2010
- Study completionMay 2011
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.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma US, Inc.
- Responsible party
- Principal investigator, Daniel S. Berman, Cedars-Sinai Medical Center
- Investigators
- Daniel S Berman, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00892307
- Sponsor's protocol ID
- IRB # 10928/11143
- Status last verified
- Nov 2013
- First submitted
- 24 Apr 2009
- Last updated
- 13 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Anatomy and Physiology Using Multidetector Dual Source Computed Tomography With Adenosine Enhancement: Comparative Study With SPECT Imaging: Pilot Studies I/II
- ClinicalTrials.gov ID
- NCT00892307
- Acronym / sponsor ID
- IRB # 10928/11143
- Conditions
- Coronary Artery Disease
- Keywords
- Diagnostic Imaging, Dual Source Multidetector Computed Tomography, Computed Tomography, CT, Single Photon Emission Computed Tomography, SPECT, Myocardial Perfusion, Atherosclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- Astellas Pharma US, Inc.
- Study start
- Feb 2007
- Primary completion
- Feb 2010 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 4 May 2009 (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.
Researchers hope that this new non-invasive multi-detector scanner (DSCT) will provide diagnostic information comparable to the combination of traditional SPECT (for function and blood flow) and CT imaging (for a precise anatomical view).
Detailed description
The DSCT scanner is able to assess cardiac blood flow (myocardial perfusion) at the same time as coronary anatomy. The results derived from these scans will be compared to standard SPECT imaging.
To further evaluate obstruction in the coronary arteries, physicians may refer for an invasive Coronary Angiogram, the current gold standard for diagnosis of Coronary Artery Disease (CAD). By validating the DSCT scanner as a system with which to assess the extent of obstruction in the coronary arteries, physicians may be able to lessen the occurrence of an invasive exam.
Procedures: Each pilot anticipates enrolling 20 subjects.
Pilot 1: Clinical Follow-up Rest/Stress Adeno-SPECT and Research Stress /Rest Adeno-DSCT obtained in the same patient during the same period of stress testing
- Radiation: Thallium injection for rest SPECT
- Drug: Single dose Adenosine Infusion for DSCT and SPECT
- Radiation: Sestamibi injection for stress SPECT
- Drug: CT contrast
- Radiation: Stress DSCT /Rest DSCT
Pilot 2: Research Stress/ Rest Adeno-DSCT obtained within 30 days of initial positive SPECT finding
- Drug: Adenosine Infusion for DSCT
- Drug: CT contrast
- Radiation: Stress DSCT /Rest DSCT
Both pilot studies will relate results to subject history, ECG and cardiac angiogram, if available
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Coronary Artery Disease
Key inclusion criteria (5 listed)
- Provide written consent and are willing to comply with protocol requirements
- Are at least 18 years of age
- Are referred for clinically-ordered SPECT
- Have known CAD
- Have had prior (within 30 days) positive Adeno-SPECT scan
Key exclusion criteria (24 listed)
- Patients being referred to invasive coronary angiography will not be included in this pilot
- Caffeine intake within the 24 hours prior to adenosine stress testing
- Pregnancy (known or suspected)
- Intolerance or contraindication to adenosine (severe Asthma…)
- Intake of methylxanthine containing medications such as theophylline that have not been withdrawn and would interfere with the effectiveness of adenosine.
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 |
|---|---|---|
| Dual Source Multidetector CT (DSCT) w/ Adenosine enhancementAlso: Dual Source Multidetector Computed Tomography, Dual Source CT, Dual Source CT with adenosine enhancement, Adenosine enhanced CTSomatom Definition Dual Source CT Scanner Stress/Rest Image scan using weight based CT contrast dye | Radiation | – |
Primary outcome
To show that adenosine enhanced DSCT will enhance regular Multidetector Spiral Computed Tomography (MSCT) "diagnostic power" to detect significant (e.g., > 50%) coronary stenosis
Time frame: One day
1 secondary outcome
To assess coronary anatomical results obtained by CT Angiography (CTA) at high heart rates in terms of the rate of assessable coronary segments.
Time frame: One day
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 13 Nov 2013.
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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.
Daniel S Berman, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Cedars-Sinai Medical Center 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 5 inclusion and 24 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 13 Nov 2013. 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?
To show that adenosine enhanced DSCT will enhance regular Multidetector Spiral Computed Tomography (MSCT) "diagnostic power" to detect significant (e.g., > 50%) coronary stenosis (time frame: One day). 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 13 Nov 2013.