Coronary Artery DiseaseNCT00348569
A Study of Computed Tomography (CT) for Evaluation of Coronary Artery Blockages in Typical or Atypical Chest Pain
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 with typical or atypical chest pain suspected of coronary artery disease (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
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 245 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to 31 Jan 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject has typical or atypical chest pain suspected of CAD and is referred for an elective coronary angiography.
- The subject must be scheduled to undergo a CATH procedure between 48 hours and 3 weeks post CCTA procedure.
- The subject must not undergo any cardiac interventional treatment between the 2 procedures.
- The subject must have sinus rhythm with stable heart rate of ≤65 beats per minute (bpm) or if heart rate was >65 bpm, the subject must agree to the use of beta-blocker(s) prior to the CT scan procedure to achieve stable heart rate of ≤65 bpm.
Who cannot join
- The subject had an established diagnosis of CAD by a) previous CATH, b) prior myocardial infarction confirmed by ECG, or c) prior revascularization (balloon angioplasty, stent placement, or CABG).
- The subject had a known allergy to iodinated contrast agent, including but not limited to hives, anaphylactoid or cardiovascular reactions, laryngeal edema and bronchospasm.
- The subject had impaired renal function with a serum creatinine level of 1.7 mg/dL (150 μmol/L) or above.
- The subject had atrial fibrillation/flutter or any irregular heart rhythm considered by the investigator to interfere with temporal acquisition of cardiac CT images.
- The subject had a resting heart rate of >100 bpm and/or a resting systolic blood pressure of <100mm Hg.
- The subject had an artificial heart valve(s).
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- The subject has had prior pacemaker or internal defibrillator lead implantation.
- The subject's resting heart rate was >65 bpm and beta-blocker therapy was contraindicated.
- The subject had a contraindication to verapamil when beta-blocker therapy could not be administered. The subject had a contraindication to nitroglycerin.
- The subject had evidence of ongoing or active clinical instability.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Multicenter Study of GE LightSpeed Volume Computed Tomography (CT) for Evaluation of Coronary Artery Blockages in Typical or Atypical Chest Pain Patients Suspected of Coronary Artery Disease
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 with typical or atypical chest pain suspected of coronary artery disease (CAD).
- Conditions
- Coronary Artery Disease
- Being tested
- 64 Channel VCT
- Keywords
- CT, Coronary, Cardiac, Angiography, X-ray, CAD, Chest pain
- Medical subject headings
- Coronary Artery Disease, Chest Pain
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 2 to 21 days later 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 posted4 Jul 2006 (estimated)
- Study startMay 2006
- Primary completion31 Jan 2007
- Study completion31 Jan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 245 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
- NCT00348569
- Sponsor's protocol ID
- GE-189-002
- Status last verified
- Apr 2019
- First submitted
- 30 Jun 2006
- Last updated
- 29 Apr 2019
- Results posted
- No
Publications
Min JK, Edwardes M, Lin FY, Labounty T, Weinsaft JW, Choi JH, Delago A, Shaw LJ, Berman DS, Budoff MJ. Relationship of coronary artery plaque composition to coronary artery stenosis severity: results from the prospective multicenter ACCURACY trial. Atherosclerosis. 2011 Dec;219(2):573-8. doi: 10.1016/j.atherosclerosis.2011.05.032. Epub 2011 May 31.
PubMed 21696739Budoff MJ, Dowe D, Jollis JG, Gitter M, Sutherland J, Halamert E, Scherer M, Bellinger R, Martin A, Benton R, Delago A, Min JK. Diagnostic performance of 64-multidetector row coronary computed tomographic angiography for evaluation of coronary artery stenosis in individuals without known coronary artery disease: results from the prospective multicenter ACCURACY (Assessment by Coronary Computed Tomographic Angiography of Individuals Undergoing Invasive Coronary Angiography) trial. J Am Coll Cardiol. 2008 Nov 18;52(21):1724-32. doi: 10.1016/j.jacc.2008.07.031.
PubMed 19007693
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Study of GE LightSpeed Volume Computed Tomography (CT) for Evaluation of Coronary Artery Blockages in Typical or Atypical Chest Pain Patients Suspected of Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT00348569
- Acronym / sponsor ID
- GE-189-002
- Conditions
- Coronary Artery Disease
- Keywords
- CT, Coronary, Cardiac, Angiography, X-ray, CAD, Chest pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- 31 Jan 2007 (actual)
- Study completion
- 31 Jan 2007 (actual)
- First posted
- 4 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 with typical or atypical chest pain suspected of coronary artery disease (CAD).
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 2 to 21 days later by catheter coronary angiography (CATH). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The subject has typical or atypical chest pain suspected of CAD and is referred for an elective coronary angiography.
- The subject must be scheduled to undergo a CATH procedure between 48 hours and 3 weeks post CCTA procedure.
- The subject must not undergo any cardiac interventional treatment between the 2 procedures.
- The subject must have sinus rhythm with stable heart rate of ≤65 beats per minute (bpm) or if heart rate was >65 bpm, the subject must agree to the use of beta-blocker(s) prior to the CT scan procedure to achieve stable heart rate of ≤65 bpm.
Key exclusion criteria (10 listed)
- The subject had an established diagnosis of CAD by a) previous CATH, b) prior myocardial infarction confirmed by ECG, or c) prior revascularization (balloon angioplasty, stent placement, or CABG).
- The subject had a known allergy to iodinated contrast agent, including but not limited to hives, anaphylactoid or cardiovascular reactions, laryngeal edema and bronchospasm.
- The subject had impaired renal function with a serum creatinine level of 1.7 mg/dL (150 μmol/L) or above.
- The subject had atrial fibrillation/flutter or any irregular heart rhythm considered by the investigator to interfere with temporal acquisition of cardiac CT images.
- The subject had a resting heart rate of >100 bpm and/or a resting systolic blood pressure of <100mm Hg.
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 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 Apr 2019.
- Derived from this study: PubMed 21696739Min JK, Edwardes M, Lin FY, Labounty T, Weinsaft JW, Choi JH, Delago A, Shaw LJ, Berman DS, Budoff MJ. Relationship of coronary artery plaque composition to coronary artery stenosis severity: results from the prospective multicenter ACCURACY trial. Atherosclerosis. 2011 Dec;219(2):573-8. doi: 10.1016/j.atherosclerosis.2011.05.032. Epub 2011 May 31.
- Derived from this study: PubMed 19007693Budoff MJ, Dowe D, Jollis JG, Gitter M, Sutherland J, Halamert E, Scherer M, Bellinger R, Martin A, Benton R, Delago A, Min JK. Diagnostic performance of 64-multidetector row coronary computed tomographic angiography for evaluation of coronary artery stenosis in individuals without known coronary artery disease: results from the prospective multicenter ACCURACY (Assessment by Coronary Computed Tomographic Angiography of Individuals Undergoing Invasive Coronary Angiography) trial. J Am Coll Cardiol. 2008 Nov 18;52(21):1724-32. doi: 10.1016/j.jacc.2008.07.031.
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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 4 inclusion and 10 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 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 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00348569, which also lists 2 linked publications.
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 Apr 2019.