Coronary Artery DiseaseEARTHNCT02892539
Evaluation of Radiation Exposure and Risk Factors During Coronary Angiography
An observational study of Coronary Artery Disease, run by Fan Liu at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Coronary Angiography
- Type of treatment
- Surgery or procedure
- How many people
- 4,000 participants
- Where
- 1 siteChina
- Study dates
- Aug 2016to Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: residents who need to perform coronary angiography in Hebei province
Who may be able to join
- Patients who need to perform coronary angiography
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
Fan Liu, MD/PhD, +86-0311-66003972, liufantrail@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Coronary Angiography
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary AngiographyRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiation exposure of the patients
Measured: during coronary angiography procedure
Secondary outcomes (1)
Reference values for the main radiation doses parameters
Measured: during coronary angiography procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study startAug 2016
- Primary completionJul 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fan Liu
- Sponsor type
- University, hospital or other
- Collaborators
- The First Hospital of Hebei Medical University, Hebei Medical University Third Hospital, Hebei Medical University Fourth Hospital, Bethune International Peace Hospital, First Hospital of Shijiazhuang City, Xingtai People's Hospital, Cangzhou Central Hospital
- Responsible party
- Sponsor-investigator, Fan Liu, The Second Hospital of Hebei Medical University
- Investigators
- Fan Liu, MD/PhD, Principal investigator, The Second Hospital of Hebei Medical Univerisity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02892539
- Sponsor's protocol ID
- Hebei Tracking Project 2016
- Acronym
- EARTH
- Status last verified
- Sep 2016
- First submitted
- 27 Aug 2016
- Last updated
- 9 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 25065542Wassef 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.
PubMed 24746655
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Case Study to Evaluate Radiation Exposure and Risk Factors in Patients During Coronary Angiography
- ClinicalTrials.gov ID
- NCT02892539
- Acronym / sponsor ID
- EARTH / Hebei Tracking Project 2016
- Conditions
- Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Fan LiuUniversity, hospital or other
- Collaborators
- The First Hospital of Hebei Medical University, Hebei Medical University Third Hospital, Hebei Medical University Fourth Hospital, Bethune International Peace Hospital, First Hospital of Shijiazhuang City, Xingtai People's Hospital, Cangzhou Central Hospital
- Study start
- Aug 2016
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 8 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- residents who need to perform coronary angiography in Hebei province
Key inclusion criteria (1 listed)
- Patients who need to perform coronary angiography
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary Angiography | Radiation | – |
Primary outcome
Radiation exposure of the patients
Time frame: during coronary angiography procedure
1 secondary outcome
Reference values for the main radiation doses parameters
Time frame: during coronary angiography procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2016.
- Results publication: PubMed 25065542Shah 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.
- Results publication: PubMed 24746655Wassef 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fan Liu, MD/PhD principal investigator
The Second Hospital of Hebei Medical Univerisity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Fan Liu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fan Liu, MD/PhD (+86-0311-66003972, liufantrail@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiation exposure of the patients (time frame: during coronary angiography procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02892539, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2016.