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Clinical Significance of Retinal Emboli During Diagnostic and Therapeutic Cardiac Catheterization

Primary Purpose

Cardiac Catheterization, Retina, Embolism

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
diagnostic cardiac catheterization
therapeutic cardiac catheterization
Sponsored by
Shiraz University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiac Catheterization focused on measuring Catheter, coronary artery disease, embolus, stroke, retinal emboli

Eligibility Criteria

52 Years - 68 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • shiraz University of medical sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

diagnostic cardiac catheterization

therapeutic cardiac catheterization

Arm Description

patients with diagnostic cardiac catheterization

patient with angioplasty

Outcomes

Primary Outcome Measures

retinal emboli
retinal emboli detected by retinal especialist by direct examination

Secondary Outcome Measures

visual field
visual field detected by ophthalmologist
visual acuity
snellen chart by ophthalmologist

Full Information

First Posted
July 6, 2010
Last Updated
July 6, 2010
Sponsor
Shiraz University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01157338
Brief Title
Clinical Significance of Retinal Emboli During Diagnostic and Therapeutic Cardiac Catheterization
Official Title
Clinical Significance of Retinal Emboli During Diagnostic and Therapeutic Cardiac Catheterization
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Shiraz University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Catheterization, Retina, Embolism
Keywords
Catheter, coronary artery disease, embolus, stroke, retinal emboli

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
diagnostic cardiac catheterization
Arm Type
Active Comparator
Arm Description
patients with diagnostic cardiac catheterization
Arm Title
therapeutic cardiac catheterization
Arm Type
Active Comparator
Arm Description
patient with angioplasty
Intervention Type
Procedure
Intervention Name(s)
diagnostic cardiac catheterization
Intervention Description
coronary intervention: angiography
Intervention Type
Procedure
Intervention Name(s)
therapeutic cardiac catheterization
Intervention Description
cardiac catheterization: angioplasty
Primary Outcome Measure Information:
Title
retinal emboli
Description
retinal emboli detected by retinal especialist by direct examination
Secondary Outcome Measure Information:
Title
visual field
Description
visual field detected by ophthalmologist
Title
visual acuity
Description
snellen chart by ophthalmologist

10. Eligibility

Sex
All
Minimum Age & Unit of Time
52 Years
Maximum Age & Unit of Time
68 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
shiraz University of medical sciences
City
Shiraz
State/Province
Fars
ZIP/Postal Code
55318
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
21255443
Citation
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. doi: 10.1186/1471-2261-11-5.
Results Reference
derived

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Clinical Significance of Retinal Emboli During Diagnostic and Therapeutic Cardiac Catheterization

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