Prospective Randomized Trial On RadiaTion Dose Estimates Of CT AngIOgraphy In PatieNts Scanned With A 100kV Protocol (PROTECTION-II)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by Deutsches Herzzentrum Muenchen.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT00611780
First received: January 28, 2008
Last updated: August 26, 2008
Last verified: August 2008

January 28, 2008
August 26, 2008
January 2008
December 2008   (final data collection date for 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00611780 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Prospective Randomized Trial On RadiaTion Dose Estimates Of CT AngIOgraphy In PatieNts Scanned With A 100kV Protocol
Prospective Randomized Trial On RadiaTion Dose Estimates Of CT AngIOgraphy In PatieNts Scanned With A 100kV Protocol

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).

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Diagnostic
Coronary Disease
  • Radiation: tube voltage
    standard 120 kV
  • Radiation: tube voltage
    reduced voltage of 100 kV
  • Experimental: 1
    Reduced tube voltage of 100kV.
    Intervention: Radiation: tube voltage
  • Active Comparator: 2
    Standard tube voltage of 120kV.
    Intervention: Radiation: tube voltage
Hausleiter J, Martinoff S, Hadamitzky M, Martuscelli E, Pschierer I, Feuchtner GM, Catalán-Sanz P, Czermak B, Meyer TS, Hein F, Bischoff B, Kuse M, Schömig 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
January 2009
December 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • non-ECG triggered studies
  • non-coronary CTA studies, e.g. bypass graft CTAs, pre- or post EP studies, CABG planning studies
Both
18 Years and older
No
Contact: Joerg Hausleiter, MD +49 89 1218 ext 1585 hausleiter@dhm.mhn.de
Contact: Tanja Meyer, MD +49 89 1218 ext 4500 meyert@dhm.mhn.de
Germany
 
NCT00611780
GE IDE No. R00207
Yes
PD Dr. Joerg Hausleiter, Deutsches Herzzentrum
Deutsches Herzzentrum Muenchen
Not Provided
Principal Investigator: Joerg Hausleiter, MD Deutsches Herzzentrum Muenchen
Deutsches Herzzentrum Muenchen
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP