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Clinical Trials/NCT02892539
NCT02892539
Unknown
Not Applicable

A Prospective Multicenter Case Study to Evaluate Radiation Exposure and Risk Factors in Patients During Coronary Angiography

Fan Liu1 site in 1 country4,000 target enrollmentAugust 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
Fan Liu
Enrollment
4000
Locations
1
Primary Endpoint
Radiation exposure of the patients
Last Updated
9 years ago

Overview

Brief Summary

The purpose of this study is to evaluate the radiation exposure in patients undergoing coronary angiography, and to identify reference values for the main radiation doses parameters.

Detailed Description

Exposure of patients to X-rays during interventional coronary procedures may have deleterious effects, including an increased risk of developing cancer.Individual justification for the procedure and its optimization are the cornerstones of dose-reduction for patients.Radiation exposure is influenced by a variety of technical and clinical factors.Few multicenter data from large populations exist concerning the radiation doses to which patients are exposed during interventional coronary procedures.The aims of this prospective, multicenter survey is to: 1) evaluate the radiation exposure in 4000 patients undergoing coronary angiography by monitoring the parameters of Air kema,fluoroscopy Dose-area product and total Dose-area product; 2) analyze factors associated with variation in radiation dose in everyday clinical practice, such as number of frames, body surface area, sex, age, BMI, arterial approach, fluoroscopy time and so on.

Registry
clinicaltrials.gov
Start Date
August 2016
End Date
October 2018
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Fan Liu
Responsible Party
Sponsor Investigator
Principal Investigator

Fan Liu

Director of Department of Cardiology

The Second Hospital of Hebei Medical University

Eligibility Criteria

Inclusion Criteria

  • Patients who need to perform coronary angiography

Exclusion Criteria

  • Contrast medium reactions Severe cardiopulmonary insufficiency Uncontrolled severe arrhythmia Uncorrected kaliopenic, digitalism and acid-base imbalance Severe liver and renal dysfunction Hemorrhagic disease Severe infection disease Others who were unwilling to participate the study

Outcomes

Primary Outcomes

Radiation exposure of the patients

Time Frame: during coronary angiography procedure

Secondary Outcomes

  • Reference values for the main radiation doses parameters(during coronary angiography procedure)

Study Sites (1)

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