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NCT01157338 Clinical Trial

Clinical Significance of Retinal Emboli During Diagnostic and Therapeutic Cardiac Catheterization

Embolism Clinical Trial

Official title:
Clinical Significance of Retinal Emboli During Diagnostic and Therapeutic Cardiac Catheterization

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01157338
Other study ID # 1123
Secondary ID
Status Completed
Phase N/A
First received July 6, 2010
Last updated July 6, 2010
Start date October 2009
Est. completion date May 2010

Study information
Verified date July 2010
Source Shiraz University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority Iran: National health institute
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date May 2010
Est. primary completion date May 2010
Accepts healthy volunteers No
Gender Both
Age group 52 Years to 68 Years
Eligibility 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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Procedure:
• diagnostic cardiac catheterization
coronary intervention: angiography
• therapeutic cardiac catheterization
cardiac catheterization: angioplasty

Locations
Country Name City State
Iran, Islamic Republic of shiraz University of medical sciences Shiraz Fars

Sponsors (1)
Lead Sponsor Collaborator
Shiraz University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary retinal emboli retinal emboli detected by retinal especialist by direct examination Yes
Secondary visual field visual field detected by ophthalmologist Yes
Secondary visual acuity snellen chart by ophthalmologist Yes
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