International PRospective Multicenter Study On RadiaTion Dose Estimates Of Coronary CT AngIOgraphy IN Daily Practice

NCT ID: NCT00610766

Last Updated: 2008-03-17

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

COMPLETED

Total Enrollment

1965 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-01-31

Brief Summary

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Estimation of radiation dose of coronary multislice computed tomography (MSCT) angiography in daily practice in an international, multicenter and vendor-independent trial.

Detailed Description

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Prospective analysis of cardiac CT angiographies enrolled over 1 month

Collection of 1 axial data set and the "patient dose protocol" (including kV, mAs, CTDI, DLP, etc.) on a CD

Dose estimation in dose/cm with the use of a method proposed by the European Working Group for Guidelines on Quality Criteria in CT.

Assessment of diagnostic, qualitative image quality on a per-vessel basis by the participating study sites and in randomly selected cases by the primary study investigators (approximately 5-10% of patients to "spot check" interobserver variability of image quality assessments)

Assessment of image quality with the use of quantitative parameters including image noise, signal-to-noise and contrast-to-noise ratios

Conditions

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Coronary Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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1

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* assessment of coronary arteries
* acute chest pain or "triple rule out"
* evaluation after PCI (stents)
* evaluation of bypass grafts
* before or after EP study
* cardiac anomalies

Exclusion Criteria

* pregnancy
* contraindications against contrast media
Minimum Eligible Age

18 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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Deutsches Herzzentrum

Principal Investigators

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Joerg Hausleiter, MD

Role: PRINCIPAL_INVESTIGATOR

Deutsches Herzzentrum Muenchen

Locations

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Deutsches Herzzentrum Muenchen

Munich, , Germany

Site Status

Countries

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Germany

Other Identifiers

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GE IDE No. R00107

Identifier Type: -

Identifier Source: org_study_id

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