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

NCT ID: NCT01453712

Last Updated: 2011-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Control group

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

Group Type NO_INTERVENTION

Control group

Intervention Type RADIATION

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

Intervention group

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

Group Type EXPERIMENTAL

Intervention group

Intervention Type RADIATION

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

Interventions

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Control group

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

Intervention Type RADIATION

Intervention group

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

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Deutsches Herzzentrum Muenchen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joerg Hausleiter, MD

Role: PRINCIPAL_INVESTIGATOR

Deutsches Herzzentrum Muenchen

Locations

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Deutsches Herzzentrum Muenchen

Munich, Bavaria, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Joerg Hausleiter, MD

Role: CONTACT

[email protected]
49 89 1218 ext. 1585

Simon Deseive, MD

Role: CONTACT

[email protected]
49 89 1218 ext. 0

Facility Contacts

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Joerg Hausleiter, MD

Role: primary

[email protected]
49 89 1218 ext. 1585

Simon Deseive, MD

Role: backup

[email protected]
49 89 1218

References

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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.

Reference Type DERIVED
PMID: 26189118 (View on PubMed)

Other Identifiers

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GE-DHM-PROTV

Identifier Type: -

Identifier Source: org_study_id