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Clinical Significance of Retinal Emboli During Diagnostic and Therapeutic Cardiac Catheterization

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ClinicalTrials.gov Identifier: NCT01157338
Recruitment Status : Completed
First Posted : July 7, 2010
Last Update Posted : July 7, 2010
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Cardiac Catheterization Retina Embolism Procedure: diagnostic cardiac catheterization Procedure: therapeutic cardiac catheterization Not Applicable

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  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Clinical Significance of Retinal Emboli During Diagnostic and Therapeutic Cardiac Catheterization
Study Start Date : October 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

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




Primary Outcome Measures :
  1. retinal emboli
    retinal emboli detected by retinal especialist by direct examination


Secondary Outcome Measures :
  1. visual field
    visual field detected by ophthalmologist

  2. visual acuity
    snellen chart by ophthalmologist



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Ages Eligible for Study:   52 Years to 68 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01157338


Locations
Iran, Islamic Republic of
shiraz University of medical sciences
Shiraz, Fars, Iran, Islamic Republic of, 55318
Sponsors and Collaborators
Shiraz University of Medical Sciences

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Javad Kojuri, Shiraz University of medical sciences
ClinicalTrials.gov Identifier: NCT01157338     History of Changes
Other Study ID Numbers: 1123
First Posted: July 7, 2010    Key Record Dates
Last Update Posted: July 7, 2010
Last Verified: July 2010

Keywords provided by Shiraz University of Medical Sciences:
Catheter
coronary artery disease
embolus
stroke
retinal emboli

Additional relevant MeSH terms:
Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases