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Clinical Trials/NCT03634657
NCT03634657CompletedNot Applicable

Wirksamkeit Additiver Strahlenschutzvorrichtungen Zwecks Reduzierung Der Ionisierenden Streustrahlung im Herzkatheterlabor

Tommaso Gori2 sites in 1 country700 target enrollmentStarted: August 16, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
700
Locations
2
Primary Endpoint
Operator dose

Study Overview

Brief Summary

This study evaluates the radiation exposure of scattered radiation for the interventionalist during coronary angiography using different X-ray protection materials, namely, an X-ray Screen without additional X-ray protection, an X-ray Screen with additional protective strips and an X-ray Screen with additional protective strips AND protective patient cut-outs.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • indication for coronary angiography

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Operator dose

Time Frame: Duration of coronary angiography of individuel patient, varies between approximately 5 minutes of radiation (easy access, exclusion coronary heart disease) and app. 3 hours (difficult and complex percutaneous coronary intervention).

Dose of radiation measured

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Tommaso Gori

Director, Cardiac Catheterization Laboratory ; Director, Study center of Center for Cardiology, university hospital Mainz

Johannes Gutenberg University Mainz

Study Sites (2)

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