Coronary Artery DiseasePhase 4PROTECTION-VNCT01453712
Prospective Randomized Trial On Radiation Dose Estimates Of CT Angiography In Patients Applying Iterative Image Reconstruction Techniques - The PROTECTION V Study -
A Phase 4 study testing Intervention group in people with Coronary Artery Disease, run by Deutsches Herzzentrum Muenchen at 1 site in Germany.
Trial summary
The objective of this study is to compare a standard coronary CT angiography scan protocol with conventional image reconstruction with a scan protocol using reduced tube current and a new image reconstruction algorithm. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Intervention group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2011to Dec 2012
- Phase
- Phase 4
- 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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with an indication for a coronary CT angiography (planned evaluation of the coronary arteries)
- signed informed consent
- stable sinus rhythm
- age > 18 years
Who cannot join
- known allergy to contrast agents.
- patients with known coronary artery disease
- pregnancy
- no stable sinus rhythm
- coronary ct examinations not focussing on coronary arteries
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Deutsches Herzzentrum Muenchen
Munich, Bavaria, 80636
Joerg Hausleiter, MD, 49 89 1218 ext. 1585, hausleiter@dhm.mhn.de
Simon Deseive, MD, 49 89 1218, deseive@dhm.mhn.de
About this study
The objective of this study is to compare a standard coronary CT angiography scan protocol with conventional image reconstruction with a scan protocol using reduced tube current and a new image reconstruction algorithm. The investigators hypothesize that the image quality of the new scan protocol is not inferior, while radiation dose estimates are reduced by around 30%.
Secondary endpoints of the study include quantitative image quality parameters, prevalence of non-diagnostic studies, prevalence of coronary artery plaques and plaque characteristics (calcified, non-calcified, mixed) and prevalence of follow-up examinations.
- Conditions
- Coronary Artery Disease
- Being tested
- Control group, Intervention group
- Keywords
- coronary artery disease, coronary CT angiography, radiation dose, iterative image reconstruction, detection
- 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.
Control groupRadiation
Conventional coronary CT angiography using standard reconstruction technique (filtered back projection).
Intervention groupRadiation
Using the new scan protocol with 30 % less tube current and iterative image reconstruction algorithm.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Conventional coronary CT angiography using standard reconstruction technique (filtered back projection). Receives: Radiation: Control group |
| Intervention group | Experimental | Using the new scan protocol with 30 % less tube current and iterative image reconstruction algorithm. Receives: Radiation: Intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Image quality
Compared with a conventional scan protocol the use of a new scan protocol using iterative image reconstruction and reduced tube current is associated with a comparable diagnostic image quality, while the radiation dose estimates are significantly reduced.
Measured: 1 month
Secondary outcomes (5)
Quantitative image quality parameters
Quantitative image quality parameters, e.g. image noise, signal and contrast intensity, signal- and contrast-to-noise-ratios
Measured: 1 month
Prevalence of non-diagnostic examinations
Prevalence of non-diagnostic examinations in both study arms.
Measured: 1 month
Prevalence of coronary artery plaques
Prevalence of coronary artery plaques and coronary artery plaques characteristics (non-calcified, calcified, mixed) in both study arms.
Measured: 1 month
Prevalence of follow-up examinations
Prevalence of follow-up examinations in both study arms.
Measured: 1 month
Radiation dose
Radiation dose in both study arms.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joerg Hausleiter, MD, Principal investigator, Deutsches Herzzentrum Muenchen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01453712
- Sponsor's protocol ID
- GE-DHM-PROTV
- Acronym
- PROTECTION-V
- Status last verified
- Oct 2011
- First submitted
- 14 Oct 2011
- Last updated
- 18 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Deseive S, Chen MY, Korosoglou G, Leipsic J, Martuscelli E, Carrascosa P, Mirsadraee S, White C, Hadamitzky M, Martinoff S, Menges AL, Bischoff B, Massberg S, Hausleiter J. Prospective Randomized Trial on Radiation Dose Estimates of CT Angiography Applying Iterative Image Reconstruction: The PROTECTION V Study. JACC Cardiovasc Imaging. 2015 Aug;8(8):888-96. doi: 10.1016/j.jcmg.2015.02.024. Epub 2015 Jul 15.
PubMed 26189118
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial On Radiation Dose Estimates Of CT Angiography In Patients Applying Iterative Image Reconstruction Techniques - The PROTECTION V Study -
- ClinicalTrials.gov ID
- NCT01453712
- Acronym / sponsor ID
- PROTECTION-V / GE-DHM-PROTV
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery disease, coronary CT angiography, radiation dose, iterative image reconstruction, detection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Dec 2012 (estimated)
- First posted
- 18 Oct 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.
The objective of this study is to compare a standard coronary CT angiography scan protocol with conventional image reconstruction with a scan protocol using reduced tube current and a new image reconstruction algorithm. The investigators hypothesize that the image quality of the new scan protocol is not inferior, while radiation dose estimates are reduced by around 30%.
Secondary endpoints of the study include quantitative image quality parameters, prevalence of non-diagnostic studies, prevalence of coronary artery plaques and plaque characteristics (calcified, non-calcified, mixed) and prevalence of follow-up examinations.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | Radiation: Control groupConventional coronary CT angiography using standard reconstruction technique (filtered back projection). |
| Intervention group | Experimental | Radiation: Intervention groupUsing the new scan protocol with 30 % less tube current and iterative image reconstruction algorithm. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients with an indication for a coronary CT angiography (planned evaluation of the coronary arteries)
- signed informed consent
- stable sinus rhythm
- age > 18 years
Key exclusion criteria (5 listed)
- known allergy to contrast agents.
- patients with known coronary artery disease
- pregnancy
- no stable sinus rhythm
- coronary ct examinations not focussing on coronary arteries
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 |
|---|---|---|
| Control groupConventional coronary CT angiography using standard reconstruction technique (filtered back projection). | Radiation | Control group |
| Intervention groupUsing the new scan protocol with 30 % less tube current and iterative image reconstruction algorithm. | Radiation | Intervention group |
Primary outcome
Image quality
Time frame: 1 month
Compared with a conventional scan protocol the use of a new scan protocol using iterative image reconstruction and reduced tube current is associated with a comparable diagnostic image quality, while the radiation dose estimates are significantly reduced.
5 secondary outcomes
Quantitative image quality parameters
Time frame: 1 month
Prevalence of non-diagnostic examinations
Time frame: 1 month
Prevalence of coronary artery plaques
Time frame: 1 month
Prevalence of follow-up examinations
Time frame: 1 month
Radiation dose
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2011.
- Derived from this study: PubMed 26189118Deseive S, Chen MY, Korosoglou G, Leipsic J, Martuscelli E, Carrascosa P, Mirsadraee S, White C, Hadamitzky M, Martinoff S, Menges AL, Bischoff B, Massberg S, Hausleiter J. Prospective Randomized Trial on Radiation Dose Estimates of CT Angiography Applying Iterative Image Reconstruction: The PROTECTION V Study. JACC Cardiovasc Imaging. 2015 Aug;8(8):888-96. doi: 10.1016/j.jcmg.2015.02.024. Epub 2015 Jul 15.
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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.
Joerg Hausleiter, MD principal investigator
Deutsches Herzzentrum Muenchen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intervention group in people with Coronary Artery Disease, run by Deutsches Herzzentrum Muenchen at 1 site in Germany.
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 5 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: status not confirmed, as of the sponsor's last update on 18 Oct 2011. 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 Germany. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joerg Hausleiter, MD (49 89 1218 ext. 1585, hausleiter@dhm.mhn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Image quality (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01453712, which also lists 1 linked publication.
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 18 Oct 2011.