A Phase 4 interventional study of tube voltage and tube voltage in Coronary Disease, sponsored by Deutsches Herzzentrum Muenchen. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-08-27.
Sponsored by Deutsches Herzzentrum Muenchen · Phase 4, Interventional, and Diagnostic
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
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).
2,839 studies on the registry are indexed under Coronary Disease; 311 are open to participants now.
This study's planned enrollment of 400 is above the median of 124 across 1,583 interventional studies indexed under Coronary Disease.
Browse Coronary Disease studies →Deutsches Herzzentrum Muenchen is the lead sponsor of 112 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Reduced tube voltage of 100kV.
Radiation: tube voltage
Standard tube voltage of 120kV.
Radiation: tube voltage
standard 120 kV
reduced voltage of 100 kV
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
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
This study is status unknown, as verified in Aug 2008. You cannot join it, but the record below documents what was studied.
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Deutsches Herzzentrum Muenchen