Clinical Significance of Retinal Emboli During Diagnostic and Therapeutic Cardiac Catheterization

This study has been completed.

Sponsor:

Information provided by:

Shiraz University of Medical Sciences

ClinicalTrials.gov Identifier:

NCT01157338

First received: July 6, 2010

Last updated: NA

Last verified: July 2010

History: No changes posted

Tracking Information
First Received Date ^ICMJE	July 6, 2010
Last Updated Date	July 6, 2010
Start Date ^ICMJE	October 2009
Primary Completion Date	May 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 6, 2010)	retinal emboli [ Designated as safety issue: Yes ] retinal emboli detected by retinal especialist by direct examination
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: July 6, 2010)	visual field [ Designated as safety issue: Yes ] visual field detected by ophthalmologist visual acuity [ Designated as safety issue: Yes ] snellen chart by ophthalmologist
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Clinical Significance of Retinal Emboli During Diagnostic and Therapeutic Cardiac Catheterization
Official Title ^ICMJE	Clinical Significance of Retinal Emboli During Diagnostic and Therapeutic Cardiac Catheterization
Brief Summary	Retinal emboli is a common phenomenon in cardiac catheterization. In this study the investigators evaluate the incidence of retinal emboli post diagnostic and therapeutic cardiac catheterization over 300 patients. The incidence was 6.3% and had no clinical sequel on visual acuity and visual field.
Detailed Description	Background and Purpose Cardiac catheterization may cause retinal embolization, a risk factor for cerebrovascular emboli and stroke. We describe the incidence of clinically silent and apparent retinal emboli following diagnostic and interventional coronary catheterization and associated risk factors. Methods Three hundred selected patients attending a tertiary referral center for diagnostic and therapeutic cardiac catheterization were studied. Direct retinal examination and examination of the visual field and acuity were done before and after catheterization by a retinal specialist.
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Condition ^ICMJE	Cardiac Catheterization Retina Embolism
Intervention ^ICMJE	Procedure: diagnostic cardiac catheterization coronary intervention: angiography Procedure: therapeutic cardiac catheterization cardiac catheterization: angioplasty
Study Arm (s)	Active Comparator: diagnostic cardiac catheterization patients with diagnostic cardiac catheterization Intervention: Procedure: diagnostic cardiac catheterization Active Comparator: therapeutic cardiac catheterization patient with angioplasty Intervention: Procedure: therapeutic cardiac catheterization
Publications *	Kojuri J, Mehdizadeh M, Rostami H, Shahidian D. Clinical significance of retinal emboli during diagnostic and therapeutic cardiac catheterization in patients with coronary artery disease. BMC Cardiovasc Disord. 2011 Jan 21;11:5.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	300
Completion Date	May 2010
Primary Completion Date	May 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: every patient with diagnostic and therapeutic cardiac catheterization Exclusion Criteria: patient refusal to follow up ophthalmology abscence of coronary disease in angiogram abnormal retinal angiogram prior to study
Gender	Both
Ages	52 Years to 68 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Iran, Islamic Republic of

Administrative Information
NCT Number ^ICMJE	NCT01157338
Other Study ID Numbers ^ICMJE	1123
Has Data Monitoring Committee	Yes
Responsible Party	Dr Javad Kojuri, Shiraz University of medical sciences
Study Sponsor ^ICMJE	Shiraz University of Medical Sciences
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Shiraz University of Medical Sciences
Verification Date	July 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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