Coronary Artery DiseaseNCT00622167
Comparison of DSCT With IB-IVUS and Angiography in the Assessment of Coronary Artery Disease
A study testing Integrated Backscatter IVUS and Dual Source Computed Tomography in people with Coronary Artery Disease, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this study is to compare different methods of looking at atherosclerotic plaques in heart arteries. Identifying the characteristics of these plaques noninvasively would be very valuable. 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?
- Integrated Backscatter IVUS and Dual Source Computed Tomography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Jun 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
- Males or non-pregnant females
- > / = 18 years of age
- Scheduled for coronary angiography
Who cannot join
- Acute ST-elevation myocardial infarction within last 72 hours
- Current congestive heart failure
- Current cardiogenic shock
- Unstable clinical condition
- Known cardiomyopathy (EF < 30%)
- Creatinine >1.5 mg/dL
Show all 16Show fewer
- Definite allergy to iodinated contrast media
- Current participation in an investigational drug or device research study
- HR > 65 and contraindications to the administration of beta blockers
- Exclusion criteria assessed during catheterization procedure
- PCI of native coronary vessel not performed
- Left main stenosis > 50%
- Any vessel contraindicated for IVUS imaging
- Any lesion contraindicated for IVUS imaging
- Inability to pass IVUS catheter
- PCI of bifurcation lesion
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Comparison of Dual Source Computed Tomography (DSCT) With Integrated Backscatter Intravascular Ultrasound (IB-IVUS) and Contrast Angiography in the Assessment of Coronary Artery Disease
The purpose of this study is to compare different methods of looking at atherosclerotic plaques in heart arteries. Identifying the characteristics of these plaques noninvasively would be very valuable. This study is looking at a new CT scanner (DSCT) to noninvasively image these plaques compared to invasive ultrasound (the current standard).
Read the detailed description
The primary objectives of this study are:
- To compare with contrast angiography, the ability of DSCT to detect and quantify coronary artery stenoses.
- To compare with gray-scale IVUS, the ability of DSCT to quantify plaque cross-sectional diameter \& area measurements \& plaque volume.
- To evaluate the ability of DSCT to assess plaque morphology and quantify plaque components as compared to gray-scale and IB-IVUS.
- To evaluate the ability of DSCT to identify \& measure lesion remodeling compared to gray-scale IVUS.
- To determine if pre-PCI evaluation of coronary plaque morphology by IB-IVUS can a) predict procedural success as assessed by adequate stent strut apposition and expansion and b) peri-procedural myocardial necrosis as measured by biomarker elevation.
- Conditions
- Coronary Artery Disease
- Being tested
- Integrated Backscatter IVUS, Dual Source Computed Tomography
- Keywords
- Plaque characteristics, DSCT, IVUS
- 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.
Integrated Backscatter IVUSDevice
All subjects have Integrated Backscatter IVUS and Dual Source CT imaging.
Dual Source Computed TomographyDevice
All subjects have DSCT and IBIVUS imaging
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | All patients will receive integrated backscatter IVUS and dual source CT. Receives: Device: Integrated Backscatter IVUS; Device: Dual Source Computed Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Plaque Characteristics Between DSCT (Dual Source Computed Tomography) and IVUS (Intravascular Ultrasound).
Characteristics include plaque cross-sectional diameter, area measurements, plaque volume, and plaque morphology (composition).
Measured: At time of imaging
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionApr 2008
- Study completionJun 2009
Why it stopped: Subject recruitment was slow, so enrollment has been closed.
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 Massachusetts General HospitalThe 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ik-Kyung Jang, MD, PhD, Massachusetts General Hospital
- Investigators
- Ik-Kyung Jang, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00622167
- Sponsor's protocol ID
- 2007P001842
- Status last verified
- Jan 2012
- First submitted
- 12 Feb 2008
- Last updated
- 3 Feb 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Dual Source Computed Tomography (DSCT) With Integrated Backscatter Intravascular Ultrasound (IB-IVUS) and Contrast Angiography in the Assessment of Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT00622167
- Acronym / sponsor ID
- 2007P001842
- Conditions
- Coronary Artery Disease
- Keywords
- Plaque characteristics, DSCT, IVUS
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Subject recruitment was slow, so enrollment has been closed.
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Apr 2008 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 22 Feb 2008 (estimated)
- Results
- Posted 3 Feb 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare different methods of looking at atherosclerotic plaques in heart arteries. Identifying the characteristics of these plaques noninvasively would be very valuable. This study is looking at a new CT scanner (DSCT) to noninvasively image these plaques compared to invasive ultrasound (the current standard).
Detailed description
The primary objectives of this study are:
- To compare with contrast angiography, the ability of DSCT to detect and quantify coronary artery stenoses.
- To compare with gray-scale IVUS, the ability of DSCT to quantify plaque cross-sectional diameter \& area measurements \& plaque volume.
- To evaluate the ability of DSCT to assess plaque morphology and quantify plaque components as compared to gray-scale and IB-IVUS.
- To evaluate the ability of DSCT to identify \& measure lesion remodeling compared to gray-scale IVUS.
- To determine if pre-PCI evaluation of coronary plaque morphology by IB-IVUS can a) predict procedural success as assessed by adequate stent strut apposition and expansion and b) peri-procedural myocardial necrosis as measured by biomarker elevation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Device: Integrated Backscatter IVUS, Device: Dual Source Computed TomographyAll patients will receive integrated backscatter IVUS and dual source CT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males or non-pregnant females
- > / = 18 years of age
- Scheduled for coronary angiography
Key exclusion criteria (16 listed)
- Acute ST-elevation myocardial infarction within last 72 hours
- Current congestive heart failure
- Current cardiogenic shock
- Unstable clinical condition
- Known cardiomyopathy (EF < 30%)
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 |
|---|---|---|
| Integrated Backscatter IVUSAll subjects have Integrated Backscatter IVUS and Dual Source CT imaging. | Device | 1 |
| Dual Source Computed TomographyAll subjects have DSCT and IBIVUS imaging | Device | 1 |
Primary outcome
Comparison of Plaque Characteristics Between DSCT (Dual Source Computed Tomography) and IVUS (Intravascular Ultrasound).
Time frame: At time of imaging
Characteristics include plaque cross-sectional diameter, area measurements, plaque volume, and plaque morphology (composition).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2012.
- 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.
Ik-Kyung Jang, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Backscatter IVUS and Dual Source Computed Tomography in people with Coronary Artery Disease, run by Massachusetts General Hospital 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 16 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 3 Feb 2012. 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 3 Feb 2012). 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?
Comparison of Plaque Characteristics Between DSCT (Dual Source Computed Tomography) and IVUS (Intravascular Ultrasound). (time frame: At time of imaging). 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 3 Feb 2012.