Coronary DiseasePhase 4PROTECTION-IINCT00611780
Prospective Randomized Trial On RadiaTion Dose Estimates Of CT AngIOgraphy In PatieNts Scanned With A 100kV Protocol
A Phase 4 study testing tube voltage in people with Coronary Disease, run by Deutsches Herzzentrum Muenchen at 1 site in Germany.
Trial summary
The objective of this study is to compare radiation dose of a 100kV scan protocol to the standard 120kV scan protocol. We hypothesize that the 100kV scan protocol is associated with a reduction in dose estimates of at least 20%, while the diagnostic image quality is not inferior. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Disease
- What is being tested?
- tube voltage
- 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
- Jan 2008to Jan 2009
- 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 years and older
- 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)
- stable sinus rhythm
- patient weight < 90kg or body mass index < 30 kg/m2
- signed informed consent
Who cannot join
- non-ECG triggered studies
- non-coronary CTA studies, e.g. bypass graft CTAs, pre- or post EP studies, CABG planning studies
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Deutsches Herzzentrum Muenchen
Munich, 80636
Joerg Hausleiter, MD, +49 89 1218-0 ext. 1585, hausleiter@dhm.mhn.de
Joerg Hausleiter, MD
About this study
The objective of this study is to compare radiation dose of a 100kV scan protocol to the standard 120kV scan protocol. We hypothesize that the 100kV scan protocol is associated with a reduction in dose estimates of at least 20%, while the diagnostic image quality is not inferior.
Secondary endpoints of the study include quantitative image quality parameters, diagnostic accuracy for 120 vs.100kV studies compared to invasive angiography in patients who underwent subsequent invasive coronary angiography
Read the detailed description
All patients scheduled for a coronary CT scan are screened for inclusion and exclusion criteria. Patients are included if they have stable sinus rhythm (heart rate <100 bpm) and a body weight < 90 kg or a body mass index (BMI) < 30. Informed signed consent is obtained from these patients and the CT scan is prepared. After topogram scan and the native scan for Ca-Scoring, patients are randomized in two groups with the use of sealed envelopes. After that contrast-enhanced coronary CT angiography is performed with the 120kV- or 100kV-protocol.
The CT examination is evaluated by two experienced investigators on a per-vessel basis and all results and study-related data are collected in a dedicated database. For assessment of image quality, a previously established 4-point score system is used and quantitative image quality parameters are measured.
A 30 day follow-up after the CT examination aims to evaluate if patients underwent invasive coronary angiography or were scheduled for a myocardial stress / perfusion test (such as stress-echocardiography, myocardial scintigraphy or stress perfusion imaging by MRI).
- Conditions
- Coronary Disease
- Being tested
- tube voltage
- Keywords
- Coronary CT angiography, Radiation dose estimates
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tube voltageRadiation
standard 120 kV
tube voltageRadiation
reduced voltage of 100 kV
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Reduced tube voltage of 100kV. Receives: Radiation: tube voltage |
| 2 | Active comparator | Standard tube voltage of 120kV. Receives: Radiation: tube voltage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compared with a 120kV protocol the use of a 100kV scan protocol is associated with a reduction in dose estimates of at least 20%, while the diagnostic image quality is not inferior.
Measured: 30 days
Secondary outcomes (3)
impact of the 100kV scan protocol on quantitative image quality parameters, e.g. image noise, signal and contrast intensity, signal- and contrast-to-noise-ratios
Measured: 30 days
diagnostic accuracy (sensitivity, specificity as well as positive and negative predictive values) for 120kV vs. 100 kV studies when compared with invasive coronary angiography on a per-vessel based analysis.
Measured: 30 days
frequency of non-diagnostic CTA studies when comparing 120kV and 100kV
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionDec 2008 (estimated)
- Study completionJan 2009 (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 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
- Investigators
- Joerg Hausleiter, MD, Principal investigator, Deutsches Herzzentrum Muenchen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00611780
- Sponsor's protocol ID
- GE IDE No. R00207
- Acronym
- PROTECTION-II
- Status last verified
- Aug 2008
- First submitted
- 28 Jan 2008
- Last updated
- 27 Aug 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hausleiter J, Martinoff S, Hadamitzky M, Martuscelli E, Pschierer I, Feuchtner GM, Catalan-Sanz P, Czermak B, Meyer TS, Hein F, Bischoff B, Kuse M, Schomig A, Achenbach S. Image quality and radiation exposure with a low tube voltage protocol for coronary CT angiography results of the PROTECTION II Trial. JACC Cardiovasc Imaging. 2010 Nov;3(11):1113-23. doi: 10.1016/j.jcmg.2010.08.016.
PubMed 21070998
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2008. 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 Scanned With A 100kV Protocol
- ClinicalTrials.gov ID
- NCT00611780
- Acronym / sponsor ID
- PROTECTION-II / GE IDE No. R00207
- Conditions
- Coronary Disease
- Keywords
- Coronary CT angiography, Radiation dose estimates
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2008 (estimated)
- Study completion
- Jan 2009 (estimated)
- First posted
- 11 Feb 2008 (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 radiation dose of a 100kV scan protocol to the standard 120kV scan protocol. We hypothesize that the 100kV scan protocol is associated with a reduction in dose estimates of at least 20%, while the diagnostic image quality is not inferior.
Secondary endpoints of the study include quantitative image quality parameters, diagnostic accuracy for 120 vs.100kV studies compared to invasive angiography in patients who underwent subsequent invasive coronary angiography
Detailed description
All patients scheduled for a coronary CT scan are screened for inclusion and exclusion criteria. Patients are included if they have stable sinus rhythm (heart rate <100 bpm) and a body weight < 90 kg or a body mass index (BMI) < 30. Informed signed consent is obtained from these patients and the CT scan is prepared. After topogram scan and the native scan for Ca-Scoring, patients are randomized in two groups with the use of sealed envelopes. After that contrast-enhanced coronary CT angiography is performed with the 120kV- or 100kV-protocol.
The CT examination is evaluated by two experienced investigators on a per-vessel basis and all results and study-related data are collected in a dedicated database. For assessment of image quality, a previously established 4-point score system is used and quantitative image quality parameters are measured.
A 30 day follow-up after the CT examination aims to evaluate if patients underwent invasive coronary angiography or were scheduled for a myocardial stress / perfusion test (such as stress-echocardiography, myocardial scintigraphy or stress perfusion imaging by MRI).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Radiation: tube voltageReduced tube voltage of 100kV. |
| 2 | Active comparator | Radiation: tube voltageStandard tube voltage of 120kV. |
Who may qualify
- Ages
- 18 years and older
- 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)
- stable sinus rhythm
- patient weight < 90kg or body mass index < 30 kg/m2
- signed informed consent
Key exclusion criteria (2 listed)
- non-ECG triggered studies
- non-coronary CTA studies, e.g. bypass graft CTAs, pre- or post EP studies, CABG planning studies
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 |
|---|---|---|
| tube voltagestandard 120 kV | Radiation | 2 |
| tube voltagereduced voltage of 100 kV | Radiation | 1 |
Primary outcome
Compared with a 120kV protocol the use of a 100kV scan protocol is associated with a reduction in dose estimates of at least 20%, while the diagnostic image quality is not inferior.
Time frame: 30 days
3 secondary outcomes
impact of the 100kV scan protocol on quantitative image quality parameters, e.g. image noise, signal and contrast intensity, signal- and contrast-to-noise-ratios
Time frame: 30 days
diagnostic accuracy (sensitivity, specificity as well as positive and negative predictive values) for 120kV vs. 100 kV studies when compared with invasive coronary angiography on a per-vessel based analysis.
Time frame: 30 days
frequency of non-diagnostic CTA studies when comparing 120kV and 100kV
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2008.
- Derived from this study: PubMed 21070998Hausleiter J, Martinoff S, Hadamitzky M, Martuscelli E, Pschierer I, Feuchtner GM, Catalan-Sanz P, Czermak B, Meyer TS, Hein F, Bischoff B, Kuse M, Schomig A, Achenbach S. Image quality and radiation exposure with a low tube voltage protocol for coronary CT angiography results of the PROTECTION II Trial. JACC Cardiovasc Imaging. 2010 Nov;3(11):1113-23. doi: 10.1016/j.jcmg.2010.08.016.
Related trials for Coronary Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
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 tube voltage in people with Coronary 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 2 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 27 Aug 2008. 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?
Compared with a 120kV protocol the use of a 100kV scan protocol is associated with a reduction in dose estimates of at least 20%, while the diagnostic image quality is not inferior. (time frame: 30 days). 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 NCT00611780, 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 27 Aug 2008.