- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02892539
Evaluation of Radiation Exposure and Risk Factors During Coronary Angiography (EARTH)
September 8, 2016 updated by: Fan Liu
A Prospective Multicenter Case Study to Evaluate Radiation Exposure and Risk Factors in Patients During Coronary Angiography
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
4000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Fan Liu, MD/PhD
- Phone Number: +86-0311-66003972
- Email: liufantrail@163.com
Study Locations
-
-
Hebei
-
Shijiazhuang, Hebei, China, 050000
- Recruiting
- The Second Hospital of Hebei Medical University
-
Contact:
- Fan Liu, MD/PhD
- Phone Number: +86-0311-66003972
- Email: liufantrail@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
residents who need to perform coronary angiography in Hebei province
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Radiation exposure of the patients
Time Frame: during coronary angiography procedure
|
during coronary angiography procedure
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reference values for the main radiation doses parameters
Time Frame: during coronary angiography procedure
|
during coronary angiography procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Fan Liu, MD/PhD, The Second Hospital of Hebei Medical Univerisity
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2016
Primary Completion (Anticipated)
July 1, 2018
Study Completion (Anticipated)
October 1, 2018
Study Registration Dates
First Submitted
August 27, 2016
First Submitted That Met QC Criteria
September 1, 2016
First Posted (Estimate)
September 8, 2016
Study Record Updates
Last Update Posted (Estimate)
September 9, 2016
Last Update Submitted That Met QC Criteria
September 8, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Hebei Tracking Project 2016
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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