NCT01453712

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P50-P75 for phase_4 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

October 14, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 18, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Last Updated

October 18, 2011

Status Verified

October 1, 2011

Enrollment Period

1.2 years

First QC Date

October 14, 2011

Last Update Submit

October 17, 2011

Conditions

Coronary Artery Disease

Keywords

coronary artery diseasecoronary CT angiographyradiation doseiterative image reconstructiondetection

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Quantitative image quality parameters

    1 month

  • Prevalence of non-diagnostic examinations

    1 month

  • Prevalence of coronary artery plaques

    1 month

  • Prevalence of follow-up examinations

    1 month

  • Radiation dose

    1 month

Study Arms (2)

Control group

NO INTERVENTION

Conventional coronary CT angiography using standard reconstruction technique (filtered back projection).

Radiation: Control group

Intervention group

EXPERIMENTAL

Using the new scan protocol with 30 % less tube current and iterative image reconstruction algorithm.

Radiation: Intervention group

Interventions

Control groupRADIATION

Conventional coronary CT angiography using standard reconstruction technique (filtered back projection).

Control group
Intervention groupRADIATION

Using the new scan protocol with 30 % less tube current and iterative image reconstruction algorithm.

Intervention group

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with an indication for a coronary CT angiography (planned evaluation of the coronary arteries)
  • signed informed consent
  • stable sinus rhythm
  • age \> 18 years

You may not qualify if:

  • known allergy to contrast agents.
  • patients with known coronary artery disease
  • pregnancy
  • no stable sinus rhythm
  • coronary ct examinations not focussing on coronary arteries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deutsches Herzzentrum Muenchen

Munich, Bavaria, 80636, Germany

RECRUITING

Related Publications (1)

  • 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.

    PMID: 26189118DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Joerg Hausleiter, MD

    Deutsches Herzzentrum Muenchen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joerg Hausleiter, MD

CONTACT

49 89 1218hausleiter@dhm.mhn.de

Simon Deseive, MD

CONTACT

49 89 1218deseive@dhm.mhn.de

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
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2011

First Posted

October 18, 2011

Study Start

October 1, 2011

Primary Completion

December 1, 2012

Last Updated

October 18, 2011

Record last verified: 2011-10

Locations

DE(1)