Coronary Artery DiseaseCTDOSENCT01272453
Computed Tomography Dose Reduction Using Sequential or Fast Pitch Sprial Technique
An observational study of Coronary Artery Disease and Aortic Aneurysm, run by Gilbert L. Raff, MD at 9 sites in 2 countries.
Trial summary
This is a prospective, controlled observational trial of patients undergoing clinically indicated cardiothoracic computed tomography (CT), including pulmonary or aortic angiography and coronary CT angiography (CCTA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Aortic Aneurysm, Pulmonary Embolism
- How many people
- 2,640 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Jan 2011to Oct 2013
- 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: Patients undergoing clinically indicated cardiothoracic computed tomography (CT), including pulmonary or aortic angiography and coronary CT angiography (CCTA)at 10 sites. Patient selection will be based on a site consecutive CT scan log.
Who may be able to join
- Scans from patients undergoing clinically indicated pulmonary angiography, aortography and/or CCTA.
- Age greater than or equal to 18 years.
Who cannot join
- No exclusions
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States8 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Medical University of South Carolina
Charleston, South Carolina, 29425
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Minneapolis Heart Institute/ Abbott Northwestern
Minneapolis, Minnesota, 55407
NYU Langone Medical Center
New York, New York, 10006
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan, 48073
Naval Medical Center
San Diego, California, 92134
William Beaumont Hospital-Troy
Troy, Michigan, 48085
Saudi Arabia1 site
King Abdul-Aziz Cardiac Center, national Guard Health Affairs
Riyadh, Kingdom of Saudi Arabia, 11426
About this study
Official title: Computed Tomography Dose Reduction Using Sequential or Fast Pitch Sprial Technique Employed in Cardiothoracic Imaging
This is a prospective, controlled observational trial of patients undergoing clinically indicated cardiothoracic computed tomography (CT), including pulmonary or aortic angiography and coronary CT angiography (CCTA).
Read the detailed description
The development of a novel CT scanner capable of sequential or fast-pitch spiral techniques in most patients (Siemens Definition Flash) represents a potentially crucial technical innovation at a particularly critical juncture. National healthcare systems are under pressure to deliver accurate and cost-effective diagnosis of an increasing number of patients and CT angiography in various settings is a proven, highly accurate technique that has been shown to improve diagnostic efficiency and reduce the cost of care.
However, there has been increasing concern about the lifetime attributable risk of cancer from radiation related to diagnostic procedures. Such concern extends to other radiation-based procedures that contribute to the cumulative lifetime radiation exposure of patients. The Flash scanner holds the promise of substantially reducing exposure resulting from a variety of examinations.
The CT DOSE multicenter trial is therefore designed to validate the extent of dose reduction attendant to the use of the Flash scanner in cardiothoracic scanning, and to determine whether image quality is preserved in spite of significant dose reduction.
- Conditions
- Coronary Artery Disease, Aortic Aneurysm, Pulmonary Embolism
- Keywords
- coronary artery disease, CT scan, coronary angiography, chest pain, aortic aneurysm, pulmonary embolism
- Medical subject headings
- Coronary Artery Disease, Aortic Aneurysm, Pulmonary Embolism, Chest Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Data from patients in the control group will be obtained retrospectively from patient medical records and stored image data | |
| Prospective Patient Group | Data from patients in the Flash group will be obtained prospectively from scanner consoles and medical records. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiation dose
The primary endpoint is radiation dose, measured as dose-length-product (DLP, in mGy∙cm) and effective radiation dose, calculated as DLP x 0.014 (in mSv).
Measured: Time of CT scan
Secondary outcomes (1)
Assessment of Image Quality
Signal noise (standard deviation of attenuation in Hounsfield units) will be determined in regions of interest in: A) air anterior to the chest wall, B) mid-LV septum and C) mid thoracic aorta or main PA. This will be done in a sequential sample of every 5th case (approximately 600 cases total).
Measured: Time of CT Scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionOct 2013
- Study completionOct 2013
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.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2,640 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilbert L. Raff, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Siemens Healthcare Diagnostics Inc
- Responsible party
- Sponsor-investigator, Gilbert L. Raff, MD, Corewell Health East
- Investigators
- Gilbert Raff, MD, Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01272453
- Sponsor's protocol ID
- 2010-209
- Acronym
- CTDOSE
- Status last verified
- May 2014
- First submitted
- 6 Jan 2011
- Last updated
- 30 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computed Tomography Dose Reduction Using Sequential or Fast Pitch Sprial Technique Employed in Cardiothoracic Imaging
- ClinicalTrials.gov ID
- NCT01272453
- Acronym / sponsor ID
- CTDOSE / 2010-209
- Conditions
- Coronary Artery Disease, Aortic Aneurysm, Pulmonary Embolism
- Keywords
- coronary artery disease, CT scan, coronary angiography, chest pain, aortic aneurysm, pulmonary embolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,640 participants (actual)
- Lead sponsor
- Gilbert L. Raff, MDUniversity, hospital or other
- Collaborators
- Siemens Healthcare Diagnostics Inc
- Study start
- Jan 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 7 Jan 2011 (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.
This is a prospective, controlled observational trial of patients undergoing clinically indicated cardiothoracic computed tomography (CT), including pulmonary or aortic angiography and coronary CT angiography (CCTA).
Detailed description
The development of a novel CT scanner capable of sequential or fast-pitch spiral techniques in most patients (Siemens Definition Flash) represents a potentially crucial technical innovation at a particularly critical juncture. National healthcare systems are under pressure to deliver accurate and cost-effective diagnosis of an increasing number of patients and CT angiography in various settings is a proven, highly accurate technique that has been shown to improve diagnostic efficiency and reduce the cost of care.
However, there has been increasing concern about the lifetime attributable risk of cancer from radiation related to diagnostic procedures. Such concern extends to other radiation-based procedures that contribute to the cumulative lifetime radiation exposure of patients. The Flash scanner holds the promise of substantially reducing exposure resulting from a variety of examinations.
The CT DOSE multicenter trial is therefore designed to validate the extent of dose reduction attendant to the use of the Flash scanner in cardiothoracic scanning, and to determine whether image quality is preserved in spite of significant dose reduction.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | –Data from patients in the control group will be obtained retrospectively from patient medical records and stored image data |
| Prospective Patient Group | – | –Data from patients in the Flash group will be obtained prospectively from scanner consoles and medical records. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing clinically indicated cardiothoracic computed tomography (CT), including pulmonary or aortic angiography and coronary CT angiography (CCTA)at 10 sites. Patient selection will be based on a site consecutive CT scan log.
Key inclusion criteria (2 listed)
- Scans from patients undergoing clinically indicated pulmonary angiography, aortography and/or CCTA.
- Age greater than or equal to 18 years.
Key exclusion criteria (1 listed)
- No exclusions
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
Radiation dose
Time frame: Time of CT scan
The primary endpoint is radiation dose, measured as dose-length-product (DLP, in mGy∙cm) and effective radiation dose, calculated as DLP x 0.014 (in mSv).
1 secondary outcome
Assessment of Image Quality
Time frame: Time of CT Scan
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 30 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.
Gilbert Raff, MD principal investigator
Corewell Health East
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Aortic Aneurysm, run by Gilbert L. Raff, MD at 9 sites in 2 countries.
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 1 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 30 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 9 sites in United States, Saudi Arabia. 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?
Radiation dose (time frame: Time of CT scan). 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 30 May 2014.