Coronary Artery DiseaseNCT00350506
A Trial Evaluating the Clinical Applicability, Correlation, and Modeling of Cardiac CT Using 64 Detector Row VCT
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 compare computed tomography (CT) images (pictures) of the coronary arteries using the General Electric (GE) LightSpeed VCT scanner with x-ray coronary angiography in patients referred for an x-ray coronary angiography. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- 64 Channel VCT
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Oct 2006
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for elective diagnostic catheterization OR
- Elective diagnostic catheterization has been performed within the past 2 weeks but no less than 24 hours prior to the coronary CTA procedure with no intervention performed or change of the patient clinical status.
- Age ≥18 years but ≤75 years.
Who cannot join
- Prior coronary stent implantation
- Prior coronary artery bypass grafting or other heart surgery
- Prior pacemaker or internal defibrillator lead implantation
- Prior artificial heart valve
- Biochemical renal insufficiency (CrSerum > 1.6) or on dialysis
- Resting HR > 100 at the time of enrollment
Show all 18Show fewer
- Contraindication to β-blockade or calcium channel blocker
- NYHA-IV
- High-grade atrioventricular (AV) block
- Systolic blood pressure <90 mm Hg
- Severe asthma or active bronchospasm and/or chronic obstructive pulmonary disease
- Atrial fibrillation
- Inability to provide informed consent
- Evidence of ongoing or active clinical instability
- Acute chest pain (sudden onset)
- Acute myocardial infarction
- Cardiac shock
- Acute pulmonary edema
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Non-randomized, Multi-center Trial Evaluating the Clinical Applicability, Correlation, and Modeling of Cardiac CT Using 64 Detector Row VCT
To compare computed tomography (CT) images (pictures) of the coronary arteries using the General Electric (GE) LightSpeed VCT scanner with x-ray coronary angiography in patients referred for an x-ray coronary angiography.
- 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
| Study group | Role | What they receive |
|---|---|---|
| 64 Channel VCT | Experimental | All subjects underwent Coronary Computed Tomographic Angiography (CCTA) after receiving an intravenous (IV) administration of Visipaque (320 mgI/mL), to be followed by catheter coronary angiography (CATH). Receives: Device: 64 Channel VCT |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2006 (estimated)
- Study startOct 2005
- Primary completionOct 2006
- Study completionOct 2006
Why it stopped: Sponsor decision (due to low subject enrollment)
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 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
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Centofanti, MS, Study director, GE Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00350506
- Sponsor's protocol ID
- VCT-001
- Status last verified
- Apr 2019
- First submitted
- 6 Jul 2006
- Last updated
- 30 Apr 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Non-randomized, Multi-center Trial Evaluating the Clinical Applicability, Correlation, and Modeling of Cardiac CT Using 64 Detector Row VCT
- ClinicalTrials.gov ID
- NCT00350506
- Acronym / sponsor ID
- VCT-001
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision (due to low subject enrollment)
- Enrolment
- 77 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 10 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 computed tomography (CT) images (pictures) of the coronary arteries using the General Electric (GE) LightSpeed VCT scanner with x-ray coronary angiography in patients referred for an x-ray coronary angiography.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 64 Channel VCT | Experimental | Device: 64 Channel VCTAll subjects underwent Coronary Computed Tomographic Angiography (CCTA) after receiving an intravenous (IV) administration of Visipaque (320 mgI/mL), to be followed by catheter coronary angiography (CATH). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled for elective diagnostic catheterization OR
- Elective diagnostic catheterization has been performed within the past 2 weeks but no less than 24 hours prior to the coronary CTA procedure with no intervention performed or change of the patient clinical status.
- Age ≥18 years but ≤75 years.
Key exclusion criteria (18 listed)
- Prior coronary stent implantation
- Prior coronary artery bypass grafting or other heart surgery
- Prior pacemaker or internal defibrillator lead implantation
- Prior artificial heart valve
- Biochemical renal insufficiency (CrSerum > 1.6) or on dialysis
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 VCT | Device | 64 Channel VCT |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Sponsor decision (due to low subject enrollment)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2019.
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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.
Robert Centofanti, MS study director
GE Healthcare
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 18 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 30 Apr 2019. 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 was stopped early (reason given: Sponsor decision (due to low subject enrollment)). Results are not available in the source record.
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.
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 30 Apr 2019.