Clinical Significance of Retinal Emboli During Diagnostic and Therapeutic Cardiac Catheterization

Not Applicable

Completed

• Conditions: Cardiac Catheterization; Retina; Embolism
• Interventions: Procedure: diagnostic cardiac catheterization; Procedure: therapeutic cardiac catheterization

• Registration Number: NCT01157338
• Lead Sponsor: Shiraz University of Medical Sciences

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 Timeline

• Study Start: 2009-10
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2010-07
• Study First Submitted: 2010-07-06
• Study First Submitted QC: 2010-07-06
• Last Update Submitted: 2010-07-06
• Study First Posted: 2010-07-07
• Last Update Posted: 2010-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
diagnostic cardiac catheterization	diagnostic cardiac catheterization	patients with diagnostic cardiac catheterization
therapeutic cardiac catheterization	therapeutic cardiac catheterization	patient with angioplasty

Primary Outcome Measures

Name	Time	Method
retinal emboli		retinal emboli detected by retinal especialist by direct examination

Secondary Outcome Measures

Name	Time	Method
visual field		visual field detected by ophthalmologist
visual acuity		snellen chart by ophthalmologist

Trial Locations

Locations (1)

shiraz University of medical sciences; 🇮🇷 Shiraz, Fars, Iran, Islamic Republic of