Prospective Randomized Trial On RadiaTion Dose Estimates Of CT AngIOgraphy In PatieNts Scanned With A Sequential Scan Protocol (PROTECTION-III)

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:
NCT00612092
First received: January 28, 2008
Last updated: August 26, 2008
Last verified: August 2008

January 28, 2008
August 26, 2008
May 2008
January 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00612092 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • frequency of non-diagnostic CTA studies when comparing studies scanned with the helical vs. the sequential scan protocol [ 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 Sequential Scan Protocol
Prospective Randomized Trial On RadiaTion Dose Estimates Of CT AngIOgraphy In PatieNts Scanned With A Sequential Scan Protocol

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.

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).

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: Spiral image acquisition
    standard spiral scan protocol
  • Radiation: sequential image acquisition
    sequential CT scan protocol
  • Experimental: 1
    Standard spiral CT protocol
    Intervention: Radiation: Spiral image acquisition
  • Active Comparator: 2
    Sequential CT protocol
    Intervention: Radiation: sequential image acquisition
Hausleiter J, Meyer TS, Martuscelli E, Spagnolo P, Yamamoto H, Carrascosa P, Anger T, Lehmkuhl L, Alkadhi H, Martinoff S, Hadamitzky M, Hein F, Bischoff B, Kuse M, Schömig A, Achenbach S. Image quality and radiation exposure with prospectively ECG-triggered axial scanning for coronary CT angiography: the multicenter, multivendor, randomized PROTECTION-III study. JACC Cardiovasc Imaging. 2012 May;5(5):484-93. doi: 10.1016/j.jcmg.2011.12.017.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
February 2009
January 2009   (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
  • heart rate < 75 bpm with dual-source CT or < 65 bpm with single-source CT
  • 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
 
NCT00612092
GE IDE No. R00308
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