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PROTECTION-I: International PRospective Multicenter Study On RadiaTion Dose Estimates Of Coronary CT AngIOgraphy IN Daily Practice

Sponsor
Deutsches Herzzentrum Muenchen (Other)
Overall Status
Completed
CT.gov ID
NCT00610766
Collaborator
(none)
1,965
Enrollment
1
Location
12
Duration (Months)
163.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1965 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    International PRospective Multicenter Study On RadiaTion Dose Estimates Of Coronary CT AngIOgraphy IN Daily Practice
    Study Start Date :
    Jan 1, 2007
    Actual Primary Completion Date :
    Dec 1, 2007
    Actual Study Completion Date :
    Jan 1, 2008

    Arms and Interventions

    Arm Intervention/Treatment
    1

    Outcome Measures

    Primary Outcome Measures

    1. Radiation dose estimates of coronary MSCT angiography in daily practice [1 month]

    Secondary Outcome Measures

    1. Comparison of dose estimates between 16-slice, 64-slice, DSCT and other CT systems [1 month]

    2. Frequency of dose-saving algorithm's use (e.g.: ECG-dose pulsing / Care Dose 4D / 100kv [1 month]

    3. Assessment of potentials for additional dose savings (e.g. entire scan length; the distance between scan start to begin of coronary arteries and distance end of coronary arteries to end of scan) [1 month]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Deutsches Herzzentrum Muenchen Munich Germany 80636

    Sponsors and Collaborators

    • Deutsches Herzzentrum Muenchen

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00610766
    Other Study ID Numbers:
    • GE IDE No. R00107
    First Posted:
    Feb 8, 2008
    Last Update Posted:
    Mar 17, 2008
    Last Verified:
    Mar 1, 2008
    Keywords provided by , ,
    coronary CT angiography
    radiation dose estimates
    Additional relevant MeSH terms:
    Coronary Disease

    Study Results

    No Results Posted as of Mar 17, 2008