Evaluation of Radiation Exposure and Risk Factors During Coronary Angiography

• Conditions: Coronary Artery Disease

• Registration Number: NCT02892539
• Lead Sponsor: Fan Liu

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.

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-08-27
• Status Verified: 2016-09
• Study First Submitted QC: 2016-09-01
• Study First Posted: 2016-09-08
• Last Update Submitted: 2016-09-08
• Last Update Posted: 2016-09-09
• Primary Completion: 2018-07
• Study Completion: 2018-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 4000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Radiation exposure of the patients	during coronary angiography procedure

Secondary Outcome Measures

Name	Time	Method
Reference values for the main radiation doses parameters	during coronary angiography procedure

Trial Locations

Locations (1)

The Second Hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, Hebei, China