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

This study has been completed.
Sponsor:
Information provided by:
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT00610766
First received: January 28, 2008
Last updated: March 14, 2008
Last verified: March 2008
  Purpose

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


Condition
Coronary Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: International PRospective Multicenter Study On RadiaTion Dose Estimates Of Coronary CT AngIOgraphy IN Daily Practice

Resource links provided by NLM:


Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:
  • Radiation dose estimates of coronary MSCT angiography in daily practice [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of dose estimates between 16-slice, 64-slice, DSCT and other CT systems [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Frequency of dose-saving algorithm's use (e.g.: ECG-dose pulsing / Care Dose 4D / 100kv [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Enrollment: 1965
Study Start Date: January 2007
Study Completion Date: January 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with indication for cardiac imaging by MSCT

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00610766

Locations
Germany
Deutsches Herzzentrum Muenchen
Munich, Germany, 80636
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Investigators
Principal Investigator: Joerg Hausleiter, MD Deutsches Herzzentrum Muenchen
  More Information

No publications provided

Responsible Party: PD Dr. Joerg Hausleiter, Deutsches Herzzentrum
ClinicalTrials.gov Identifier: NCT00610766     History of Changes
Other Study ID Numbers: GE IDE No. R00107
Study First Received: January 28, 2008
Last Updated: March 14, 2008
Health Authority: Germany: Ethics Commission

Keywords provided by Deutsches Herzzentrum Muenchen:
coronary CT angiography
radiation dose estimates

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on July 23, 2014