Clinical trial NCT02892539: Evaluation of Radiation Exposure and Risk Factors During Coronary Angiography
Official title: A Prospective Multicenter Case Study to Evaluate Radiation Exposure and Risk Factors in Patients During Coronary Angiography
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Lead sponsor: The Second Hospital of Hebei Medical University
Sponsor class: OTHER
Collaborators: name: The First Hospital of Hebei Medical University
name: Hebei Medical University Third Hospital
name: Hebei Medical University Fourth Hospital
name: Bethune International Peace Hospital
name: First Hospital of Shijiazhuang City
name: Xingtai People's Hospital
name: Cangzhou Central Hospital
First posted: 2016-09-08
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: residents who need to perform coronary angiography in Hebei province

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.

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

Primary outcomes:
measure: Radiation exposure of the patients
timeFrame: during coronary angiography procedure
Secondary outcomes:
measure: Reference values for the main radiation doses parameters
timeFrame: during coronary angiography procedure
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
Study officials:
affiliation: The Second Hospital of Hebei Medical Univerisity
name: Fan Liu, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.2013.11.022. Epub 2014 Apr 16.