Evaluation of Radiation Exposure and Risk Factors During Coronary Angiography

NCT ID: NCT02892539

Last Updated: 2016-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

4000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-31

Study Completion Date

2018-10-31

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Coronary Angiography

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Hospital of Hebei Medical University

OTHER

Sponsor Role collaborator

Hebei Medical University Third Hospital

OTHER

Sponsor Role collaborator

Hebei Medical University Fourth Hospital

OTHER

Sponsor Role collaborator

Bethune International Peace Hospital

OTHER

Sponsor Role collaborator

First Hospital of Shijiazhuang City

OTHER

Sponsor Role collaborator

Xingtai People's Hospital

OTHER

Sponsor Role collaborator

Cangzhou Central Hospital

OTHER

Sponsor Role collaborator

Fan Liu

OTHER

Sponsor Role lead

Responsible Party

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Fan Liu

Director of Department of Cardiology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Fan Liu, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

The Second Hospital of Hebei Medical Univerisity

Locations

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The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Fan Liu, MD/PhD

Role: CONTACT

+86-0311-66003972

Facility Contacts

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Fan Liu, MD/PhD

Role: primary

+86-0311-66003972

References

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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.

Reference Type RESULT
PMID: 25065542 (View on PubMed)

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.

Reference Type RESULT
PMID: 24746655 (View on PubMed)

Related Links

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http://www.ajronline.org/doi/abs/10.2214/AJR.09.3983

Radiation Exposure to Patients in a Multicenter Coronary Angiography Trial

Other Identifiers

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Hebei Tracking Project 2016

Identifier Type: -

Identifier Source: org_study_id

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