Prospective Randomized Trial On RadiaTion Dose Estimates Of CT AngIOgraphy In PatieNts Scanned With A 100kV Protocol (PROTECTION-II)
Recruitment status was Recruiting
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
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Diagnostic
|Official Title:||Prospective Randomized Trial On RadiaTion Dose Estimates Of CT AngIOgraphy In PatieNts Scanned With A 100kV Protocol|
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- frequency of non-diagnostic CTA studies when comparing 120kV and 100kV [ Time Frame: 30 days ] [ Designated as safety issue: No ]
|Study Start Date:||January 2008|
|Estimated Study Completion Date:||January 2009|
|Estimated Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
Reduced tube voltage of 100kV.
Radiation: tube voltage
reduced voltage of 100 kV
Active Comparator: 2
Standard tube voltage of 120kV.
Radiation: tube voltage
standard 120 kV
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00611780
|Contact: Joerg Hausleiter, MD||+49 89 1218 ext email@example.com|
|Contact: Tanja Meyer, MD||+49 89 1218 ext firstname.lastname@example.org|
|Deutsches Herzzentrum Muenchen||Recruiting|
|Munich, Germany, 80636|
|Contact: Joerg Hausleiter, MD +49 89 1218-0 ext 1585 email@example.com|
|Principal Investigator: Joerg Hausleiter, MD|
|Principal Investigator:||Joerg Hausleiter, MD||Deutsches Herzzentrum Muenchen|