Prospective Randomized Trial On RadiaTion Dose Estimates Of CT AngIOgraphy In PatieNts Scanned With A Sequential Scan Protocol (PROTECTION-III)
|ClinicalTrials.gov Identifier: NCT00612092|
Recruitment Status : Unknown
Verified August 2008 by Deutsches Herzzentrum Muenchen.
Recruitment status was: Recruiting
First Posted : February 11, 2008
Last Update Posted : August 27, 2008
The objective of this study is to compare radiation dose of a standard spiral scan with the a new sequential scan protocol. We hypothesize that the sequential 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 spiral versus sequential studies compared to invasive angiography in patients who underwent subsequent invasive coronary angiography.
|Condition or disease||Intervention/treatment||Phase|
|Coronary Disease||Radiation: Spiral image acquisition Radiation: sequential image acquisition||Phase 4|
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 <75 bpm for dual source CT and <65 bpm for 64-slice CT). 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 standard spiral protocol or with the sequential 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Prospective Randomized Trial On RadiaTion Dose Estimates Of CT AngIOgraphy In PatieNts Scanned With A Sequential Scan Protocol|
|Study Start Date :||May 2008|
|Estimated Primary Completion Date :||January 2009|
|Estimated Study Completion Date :||February 2009|
Standard spiral CT protocol
Radiation: Spiral image acquisition
standard spiral scan protocol
Active Comparator: 2
Sequential CT protocol
Radiation: sequential image acquisition
sequential CT scan protocol
- Compared with a helical scan protocol the use of a sequential scan protocol is associated with a comparable diagnostic image quality, while the radiation dose estimates are significantly reduced. [ Time Frame: 1 month ]
- impact of the sequential 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 studies scanned with helical vs. sequential scan protocol when compared with invasive coronary angiography on a per-vessel based analysis [ Time Frame: 30 days ]
- frequency of non-diagnostic CTA studies when comparing studies scanned with the helical vs. the sequential scan protocol [ Time Frame: 30 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00612092
|Contact: Joerg Hausleiter, MD||+49 89 1218 ext firstname.lastname@example.org|
|Contact: Tanja Meyer, MD||+49 89 1218 ext email@example.com|
|Deutsches Herzzentrum Muenchen||Recruiting|
|Munich, Germany, 80636|
|Contact: Joerg Hausleiter, MD +49 89 1218 ext 1585 firstname.lastname@example.org|
|Principal Investigator: Joerg Hausleiter, MD|
|Principal Investigator:||Joerg Hausleiter, MD||Deutsches Herzzentrum Muenchen|