Clinical Significance of Retinal Emboli During Diagnostic and Therapeutic Cardiac Catheterization

July 6, 2010 updated by: Shiraz University of Medical Sciences
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

52 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: diagnostic cardiac catheterization
patients with diagnostic cardiac catheterization
Procedure: diagnostic cardiac catheterization
coronary intervention: angiography
Active Comparator: therapeutic cardiac catheterization
patient with angioplasty
Procedure: therapeutic cardiac catheterization
cardiac catheterization: angioplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
retinal emboli
retinal emboli detected by retinal especialist by direct examination

Secondary Outcome Measures

Outcome Measure
Measure Description
visual field
visual field detected by ophthalmologist
visual acuity
snellen chart by ophthalmologist

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shiraz University of Medical Sciences

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

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

October 1, 2009

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

July 6, 2010

First Submitted That Met QC Criteria

July 6, 2010

First Posted (Estimate)

July 7, 2010

Study Record Updates

Last Update Posted (Estimate)

July 7, 2010

Last Update Submitted That Met QC Criteria

July 6, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1123 (WRAIR)

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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