Prospective Randomized Trial On RadiaTion Dose Estimates Of CT AngIOgraphy In PatieNts Scanned With A 100kV Protocol
PROTECTION-II
1 other identifier
interventional
400
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2008
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 28, 2008
CompletedFirst Posted
Study publicly available on registry
February 11, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2009
CompletedAugust 27, 2008
August 1, 2008
11 months
January 28, 2008
August 26, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
30 days
Secondary Outcomes (3)
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
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.
30 days
frequency of non-diagnostic CTA studies when comparing 120kV and 100kV
30 days
Study Arms (2)
1
EXPERIMENTALReduced tube voltage of 100kV.
2
ACTIVE COMPARATORStandard tube voltage of 120kV.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- non-ECG triggered studies
- non-coronary CTA studies, e.g. bypass graft CTAs, pre- or post EP studies, CABG planning studies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Deutsches Herzzentrum Muenchen
Munich, 80636, Germany
Related Publications (1)
Hausleiter J, Martinoff S, Hadamitzky M, Martuscelli E, Pschierer I, Feuchtner GM, Catalan-Sanz P, Czermak B, Meyer TS, Hein F, Bischoff B, Kuse M, Schomig 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.
PMID: 21070998DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joerg Hausleiter, MD
Deutsches Herzzentrum Muenchen
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 28, 2008
First Posted
February 11, 2008
Study Start
January 1, 2008
Primary Completion
December 1, 2008
Study Completion
January 1, 2009
Last Updated
August 27, 2008
Record last verified: 2008-08