NCT00610766

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,965

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2007

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 8, 2008

Completed
Last Updated

March 17, 2008

Status Verified

March 1, 2008

Enrollment Period

11 months

First QC Date

January 28, 2008

Last Update Submit

March 14, 2008

Conditions

Coronary Disease

Keywords

coronary CT angiographyradiation dose estimates

Outcome Measures

Primary Outcomes (1)

  • Radiation dose estimates of coronary MSCT angiography in daily practice

    1 month

Secondary Outcomes (3)

  • Comparison of dose estimates between 16-slice, 64-slice, DSCT and other CT systems

    1 month

  • Frequency of dose-saving algorithm's use (e.g.: ECG-dose pulsing / Care Dose 4D / 100kv

    1 month

  • 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

Study Arms (1)

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with indication for cardiac imaging by MSCT

You may qualify if:

  • 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

You may not qualify if:

  • pregnancy
  • contraindications against contrast media

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deutsches Herzzentrum Muenchen

Munich, 80636, Germany

Location

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Joerg Hausleiter, MD

    Deutsches Herzzentrum Muenchen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 28, 2008

First Posted

February 8, 2008

Study Start

January 1, 2007

Primary Completion

December 1, 2007

Study Completion

January 1, 2008

Last Updated

March 17, 2008

Record last verified: 2008-03

Locations

DE(1)