NCT02892539

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

August 27, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 8, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

September 9, 2016

Status Verified

September 1, 2016

Enrollment Period

1.9 years

First QC Date

August 27, 2016

Last Update Submit

September 8, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Radiation exposure of the patients

    during coronary angiography procedure

Secondary Outcomes (1)

  • Reference values for the main radiation doses parameters

    during coronary angiography procedure

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

residents who need to perform coronary angiography in Hebei province

You may qualify if:

  • Patients who need to perform coronary angiography

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

RECRUITING

Related 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.

  • 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.

Related Links

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Fan Liu, MD/PhD

    The Second Hospital of Hebei Medical Univerisity

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of Department of Cardiology

Study Record Dates

First Submitted

August 27, 2016

First Posted

September 8, 2016

Study Start

August 1, 2016

Primary Completion

July 1, 2018

Study Completion

October 1, 2018

Last Updated

September 9, 2016

Record last verified: 2016-09

Locations