Coronary Artery DiseasePICTURENCT00486447
Perfusion Imaging and CT -Understanding Relative Efficacy
A study testing 64 Channel VCT in people with Coronary Artery Disease, run by GE Healthcare at 1 site in United States.
Trial summary
To determine the relative efficacy of Cardiac Computed Tomography Angiography (CCTA) and Single Positron Emission Computed Tomography (SPECT) in patients with an intermediate risk of CAD. 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?
- 64 Channel VCT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 249 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Dec 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Patients with an intermediate probability risk for coronary artery disease.
- Subject has symptoms of suspected ischemic heart disease.
- Subject is at intermediate risk for coronary artery disease
Who cannot join
- The subject has undergone a prior CCTA within 6 months prior to entering the study.
- The subject has a documented history of CAD by CATH, myocardial infarction (MI), metal stent placement in any of the coronary vessels, or a previous coronary artery bypass graft (CABG) procedure
- The subject has hemodynamic or active clinical instability:
- Acute chest pain (sudden onset);
- Cardiac shock;
- Unstable blood pressure (BP);
- Severe congestive heart failure or acute pulmonary edema.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Multi-center Study Comparing Cardiac Computed Tomography (CT) Using a 64-detector Row Volumetric Computed Tomography (VCT) Scanner for the Detection of Coronary Artery Disease With Cardiac Radionuclide Imaging.
To determine the relative efficacy of Cardiac Computed Tomography Angiography (CCTA) and Single Positron Emission Computed Tomography (SPECT) in patients with an intermediate risk of CAD.
Read the detailed description
This study is a prospective, multi-center, within-subject comparative study. One hundred fifty (150) subjects with CATH procedures are needed in the study. Approximately 300 subjects who meet all of the inclusion/exclusion criteria will be enrolled. The study population will consist of subjects with symptoms suspected of and at intermediate-risk for ischemic heart disease, which are referred for MPS for a definitive diagnosis of CAD.
Each subject will undergo the following procedures:
- A Myocardial Perfusion Study (MPS) procedure, as standard of care;
- An IV contrast-enhanced cardiac CT (CCTA) procedure;
- A CATH procedure when the MPS and/or cardiac CT examination is deemed positive or equivocal and at the discretion of the referring physicians, as a standard-of-care procedure.
When both the MPS and CCTA are normal, the subject is not required to undergo a CATH procedure, but will enter into follow-up. The research staff at each site will perform follow-up for each subject at 12 months (± 15 days) and 24 months (± 15 days) and 36 months (± 15 days) after the completion of the cardiac CT procedure.
- Conditions
- Coronary Artery Disease
- Being tested
- 64 Channel VCT
- 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.
64 Channel VCTDevice
cardiac CT angiography exam
| Study group | Role | What they receive |
|---|---|---|
| Imaging | Experimental | General imaging subjects receiving CT exams Receives: Device: 64 Channel VCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of Significant Coronary Artery Disease Using Diagnostic Catheterization for Standard of Truth.
Number of subjects with CT for detection purposes
Measured: through study completion, an expected average of 1 year
Secondary outcomes (1)
Clinical Outcomes - EKG, Laboratory Workup, Changes in Medical Management, Downstream Cardiac Testing, Significant Coronary Interventions, and Major Cardiac Events & Long-term Outcomes (Non-fatal MI and Cardiac-related Death).
Measured: 1 year outcomes after initial MPS exam
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2007 (estimated)
- Study startJun 2007
- Primary completionApr 2008
- Study completionDec 2009
Why it stopped: Accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by GE HealthcareThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matthew Budoff, Study chair, LA Biomedical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00486447
- Sponsor's protocol ID
- GE-189-03
- Acronym
- PICTURE
- Status last verified
- Jul 2017
- First submitted
- 12 Jun 2007
- Last updated
- 23 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multi-center Study Comparing Cardiac Computed Tomography (CT) Using a 64-detector Row Volumetric Computed Tomography (VCT) Scanner for the Detection of Coronary Artery Disease With Cardiac Radionuclide Imaging.
- ClinicalTrials.gov ID
- NCT00486447
- Acronym / sponsor ID
- PICTURE / GE-189-03
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Accrual
- Enrolment
- 249 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 14 Jun 2007 (estimated)
- Results
- Posted 23 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the relative efficacy of Cardiac Computed Tomography Angiography (CCTA) and Single Positron Emission Computed Tomography (SPECT) in patients with an intermediate risk of CAD.
Detailed description
This study is a prospective, multi-center, within-subject comparative study. One hundred fifty (150) subjects with CATH procedures are needed in the study. Approximately 300 subjects who meet all of the inclusion/exclusion criteria will be enrolled. The study population will consist of subjects with symptoms suspected of and at intermediate-risk for ischemic heart disease, which are referred for MPS for a definitive diagnosis of CAD.
Each subject will undergo the following procedures:
- A Myocardial Perfusion Study (MPS) procedure, as standard of care;
- An IV contrast-enhanced cardiac CT (CCTA) procedure;
- A CATH procedure when the MPS and/or cardiac CT examination is deemed positive or equivocal and at the discretion of the referring physicians, as a standard-of-care procedure.
When both the MPS and CCTA are normal, the subject is not required to undergo a CATH procedure, but will enter into follow-up. The research staff at each site will perform follow-up for each subject at 12 months (± 15 days) and 24 months (± 15 days) and 36 months (± 15 days) after the completion of the cardiac CT procedure.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imaging | Experimental | Device: 64 Channel VCTGeneral imaging subjects receiving CT exams |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with an intermediate probability risk for coronary artery disease.
- Subject has symptoms of suspected ischemic heart disease.
- Subject is at intermediate risk for coronary artery disease
Key exclusion criteria (7 listed)
- The subject has undergone a prior CCTA within 6 months prior to entering the study.
- The subject has a documented history of CAD by CATH, myocardial infarction (MI), metal stent placement in any of the coronary vessels, or a previous coronary artery bypass graft (CABG) procedure
- The subject has hemodynamic or active clinical instability:
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 |
|---|---|---|
| 64 Channel VCTcardiac CT angiography exam | Device | Imaging |
Primary outcome
Detection of Significant Coronary Artery Disease Using Diagnostic Catheterization for Standard of Truth.
Time frame: through study completion, an expected average of 1 year
Number of subjects with CT for detection purposes
1 secondary outcome
Clinical Outcomes - EKG, Laboratory Workup, Changes in Medical Management, Downstream Cardiac Testing, Significant Coronary Interventions, and Major Cardiac Events & Long-term Outcomes (Non-fatal MI and Cardiac-related Death).
Time frame: 1 year outcomes after initial MPS exam
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Matthew Budoff study chair
LA Biomedical Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 64 Channel VCT in people with Coronary Artery Disease, run by GE Healthcare 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 3 inclusion and 7 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: stopped early, as of the sponsor's last update on 23 Aug 2017. 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?
Yes. Results are posted in the registry (first posted 23 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Detection of Significant Coronary Artery Disease Using Diagnostic Catheterization for Standard of Truth. (time frame: through study completion, an expected average of 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 23 Aug 2017.