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NCT02892539 Clinical Trial

Evaluation of Radiation Exposure and Risk Factors During Coronary Angiography

Coronary Artery Disease Clinical Trial

— EARTH  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02892539
Other study ID # Hebei Tracking Project 2016
Secondary ID
Status Recruiting
Phase N/A
First received August 27, 2016
Last updated September 8, 2016
Start date August 2016
Est. completion date October 2018

Study information
Verified date September 2016
Source The Second Hospital of Hebei Medical University
Contact Fan Liu, MD/PhD
Phone +86-0311-66003972
Email liufantrail@163.com
Is FDA regulated No
Health authority China: Health and Family Planning Commission of Hebei
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 4000
Est. completion date October 2018
Est. primary completion date July 2018
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Radiation:
• Coronary Angiography

Locations
Country Name City State
China The Second Hospital of Hebei Medical University Shijiazhuang Hebei

Sponsors (8)
Lead Sponsor Collaborator
Fan Liu Bethune International Peace Hospital, Cangzhou Central Hospital, First Hospital of Shijiazhuang City, Hebei Medical University First Hospital, Hebei Medical University Fourth Hospital, Hebei Medical University Third Hospital, Xingtai People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

Shah A, Das P, Subkovas E, Buch AN, Rees M, Bellamy C. Radiation dose during coronary angiogram: relation to body mass index. Heart Lung Circ. 2015 Jan;24(1):21-5. doi: 10.1016/j.hlc.2014.05.018. Epub 2014 Jun 23. — View Citation

Wassef AW, Hiebert B, Ravandi A, Ducas J, Minhas K, Vo M, Kass M, Parmar G, Hussain F. Radiation dose reduction in the cardiac catheterization laboratory utilizing a novel protocol. JACC Cardiovasc Interv. 2014 May;7(5):550-7. doi: 10.1016/j.jcin.2013.11. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Radiation exposure of the patients during coronary angiography procedure No
Secondary Reference values for the main radiation doses parameters during coronary angiography procedure No
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