Coronary ArteriosclerosisNCT00352937
Comparison of Cardiac Computed Tomography for the Detection of Coronary Artery Disease With Nuclear Stress Test
An observational study of Coronary Arteriosclerosis, run by Providence VA Medical Center at 1 site in United States.
Trial summary
To compare the efficacy of 16-row multi-detector CT (MDCT) with standard myocardial perfusion imaging in detecting coronary artery disease (CAD) in patients without a previously established diagnosis of CAD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Arteriosclerosis
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Dec 2009
- 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: All patients without prior CAD referred for nuclear stress testing
Who may be able to join
- Referred for a clinical indicated stress SPECT MPI
- Adequate IV access in both arms
Who cannot join
- History of coronary angioplasty or stent placement
- History of coronary bypass surgery
- Angiographic history of flow-limiting CAD
- Documented history of elevated cardiac markers
- Documented history of injury or infarct on ECG
- Absence of sinus rhythm
Show all 9Show fewer
- Current history of renal insufficiency
- Known allergy to contrast dye
- Pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Providence Veterans Affairs Medical Center
Providence, Rhode Island, 02908
About this study
To compare the efficacy of 16-row multi-detector CT (MDCT) with standard myocardial perfusion imaging in detecting coronary artery disease (CAD) in patients without a previously established diagnosis of CAD.
Read the detailed description
Nuclear stress testing is currently the established non-invasive modality in detecting flow-obstructing coronary artery disease (CAD).
Recently, multi-detector CT (MDCT) has emerged as a new modality that offers a non-invasive means to directly visualize coronary anatomy and any CAD. Studies have shown that MDCT has excellent sensitivity and a high negative predictive value in detecting significant CAD.
The purpose of this study is to compare MDCT with nuclear stress testing for detecting CAD in previously undiagnosed patients.
- Conditions
- Coronary Arteriosclerosis
- Keywords
- Coronary Arteriosclerosis, Tomography, X-Ray Computed, Tomography, Emission-Computed, Single-Photon
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Calcium score
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2006 (estimated)
- Study startMar 2006
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary ArteriosclerosisStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Providence VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Wen-Chih Wu, Providence VA Medical Center
- Investigators
- Wen-Chih Wu, MD, Principal investigator, Providence VAMCVictor H Shin, MD, Principal investigator, Providence VAMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00352937
- Sponsor's protocol ID
- 1124528
- Status last verified
- May 2014
- First submitted
- 14 Jul 2006
- Last updated
- 15 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cardiac Computed Tomography for the Detection of Coronary Artery Disease With Nuclear Stress Test
- ClinicalTrials.gov ID
- NCT00352937
- Acronym / sponsor ID
- 1124528
- Conditions
- Coronary Arteriosclerosis
- Keywords
- Coronary Arteriosclerosis, Tomography, X-Ray Computed, Tomography, Emission-Computed, Single-Photon
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Providence VA Medical CenterUS federal agency
- Study start
- Mar 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 17 Jul 2006 (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.
To compare the efficacy of 16-row multi-detector CT (MDCT) with standard myocardial perfusion imaging in detecting coronary artery disease (CAD) in patients without a previously established diagnosis of CAD.
Detailed description
Nuclear stress testing is currently the established non-invasive modality in detecting flow-obstructing coronary artery disease (CAD).
Recently, multi-detector CT (MDCT) has emerged as a new modality that offers a non-invasive means to directly visualize coronary anatomy and any CAD. Studies have shown that MDCT has excellent sensitivity and a high negative predictive value in detecting significant CAD.
The purpose of this study is to compare MDCT with nuclear stress testing for detecting CAD in previously undiagnosed patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients without prior CAD referred for nuclear stress testing
Key inclusion criteria (2 listed)
- Referred for a clinical indicated stress SPECT MPI
- Adequate IV access in both arms
Key exclusion criteria (9 listed)
- History of coronary angioplasty or stent placement
- History of coronary bypass surgery
- Angiographic history of flow-limiting CAD
- Documented history of elevated cardiac markers
- Documented history of injury or infarct on ECG
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Calcium score
Time frame: 1 year
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 15 May 2014.
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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.
Wen-Chih Wu, MD principal investigator
Providence VAMC
Victor H Shin, MD principal investigator
Providence VAMC
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 Arteriosclerosis, run by Providence VA 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 2 inclusion and 9 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 15 May 2014. 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?
Calcium score (time frame: 1 year). 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 15 May 2014.