Prospective Randomized Trial On Radiation Dose Estimates Of CT Angiography In Patients Applying Iterative Image Reconstruction Techniques - The PROTECTION V Study - (PROTECTION-V)

The objective of this study is to compare a standard coronary CT angiography scan protocol with conventional image reconstruction with a scan protocol using reduced tube current and a new image reconstruction algorithm. The investigators hypothesize that the image quality of the new scan protocol is not inferior, while radiation dose estimates are reduced by around 30%.

Secondary endpoints of the study include quantitative image quality parameters, prevalence of non-diagnostic studies, prevalence of coronary artery plaques and plaque characteristics (calcified, non-calcified, mixed) and prevalence of follow-up examinations.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Radiation: Control group; Radiation: Intervention group

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

Contacts and Locations

Study Locations

• Germany
  • Bavaria
    • Muenchen, Bavaria, Germany, 80636
      • Recruiting
      • Deutsches Herzzentrum Muenchen
      • Principal Investigator: Joerg Hausleiter, MD
      • Contact: Joerg Hausleiter, MD; Phone Number: 1585 49 89 1218; Email: hausleiter@dhm.mhn.de
      • Contact: Simon Deseive, MD; Phone Number: 49 89 1218; Email: deseive@dhm.mhn.de
      • Sub-Investigator: Simon Deseive, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. patients with an indication for a coronary CT angiography (planned evaluation of the coronary arteries)
2. signed informed consent
3. stable sinus rhythm
4. age > 18 years

Exclusion Criteria:

1. known allergy to contrast agents.
2. patients with known coronary artery disease
3. pregnancy
4. no stable sinus rhythm
5. coronary ct examinations not focussing on coronary arteries

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
No Intervention: Control group; Conventional coronary CT angiography using standard reconstruction technique (filtered back projection).	Radiation: Control group; Conventional coronary CT angiography using standard reconstruction technique (filtered back projection).
Experimental: Intervention group; Using the new scan protocol with 30 % less tube current and iterative image reconstruction algorithm.	Radiation: Intervention group; Using the new scan protocol with 30 % less tube current and iterative image reconstruction algorithm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Image quality	Compared with a conventional scan protocol the use of a new scan protocol using iterative image reconstruction and reduced tube current is associated with a comparable diagnostic image quality, while the radiation dose estimates are significantly reduced.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitative image quality parameters	Quantitative image quality parameters, e.g. image noise, signal and contrast intensity, signal- and contrast-to-noise-ratios	1 month
Prevalence of non-diagnostic examinations	Prevalence of non-diagnostic examinations in both study arms.	1 month
Prevalence of coronary artery plaques	Prevalence of coronary artery plaques and coronary artery plaques characteristics (non-calcified, calcified, mixed) in both study arms.	1 month
Prevalence of follow-up examinations	Prevalence of follow-up examinations in both study arms.	1 month
Radiation dose	Radiation dose in both study arms.	1 month

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Deseive S, Chen MY, Korosoglou G, Leipsic J, Martuscelli E, Carrascosa P, Mirsadraee S, White C, Hadamitzky M, Martinoff S, Menges AL, Bischoff B, Massberg S, Hausleiter J. Prospective Randomized Trial on Radiation Dose Estimates of CT Angiography Applying Iterative Image Reconstruction: The PROTECTION V Study. JACC Cardiovasc Imaging. 2015 Aug;8(8):888-96. doi: 10.1016/j.jcmg.2015.02.024. Epub 2015 Jul 15.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: October 14, 2011
• First Submitted That Met QC Criteria: October 17, 2011
• First Posted (Estimate): October 18, 2011

Study Record Updates

• Last Update Posted (Estimate): October 18, 2011
• Last Update Submitted That Met QC Criteria: October 17, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: coronary artery disease; coronary CT angiography; radiation dose; detection; iterative image reconstruction
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: GE-DHM-PROTV