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

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 Overview

• Status: Unknown
• Conditions: Coronary Disease
• Intervention / Treatment: Radiation: tube voltage; Radiation: tube voltage

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Munich, Germany, 80636
    • Recruiting
    • Deutsches Herzzentrum Muenchen
    • Principal Investigator: Joerg Hausleiter, MD
    • Contact: Joerg Hausleiter, MD; Phone Number: 1585 +49 89 1218-0; Email: hausleiter@dhm.mhn.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Reduced tube voltage of 100kV.	Radiation: tube voltage; standard 120 kV; Radiation: tube voltage; reduced voltage of 100 kV
Active Comparator: 2; Standard tube voltage of 120kV.	Radiation: tube voltage; standard 120 kV; Radiation: tube voltage; reduced voltage of 100 kV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Deutsches Herzzentrum Muenchen
• Investigators: Principal Investigator: Joerg Hausleiter, MD, Deutsches Herzzentrum Muenchen

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Anticipated): December 1, 2008
• Study Completion (Anticipated): January 1, 2009

Study Registration Dates

• First Submitted: January 28, 2008
• First Submitted That Met QC Criteria: January 28, 2008
• First Posted (Estimate): February 11, 2008

Study Record Updates

• Last Update Posted (Estimate): August 27, 2008
• Last Update Submitted That Met QC Criteria: August 26, 2008
• Last Verified: August 1, 2008

More Information

Terms related to this study

• Keywords: Coronary CT angiography; Radiation dose estimates
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease
• Other Study ID Numbers: GE IDE No. R00207