Clinical Significance of Retinal Emboli During Diagnostic and Therapeutic Cardiac Catheterization

• Sponsor: Shiraz University of Medical Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT01157338
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Arms: 2
• Duration (Months): 7
• Patients Per Site Per Month: 43.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Catheterization; Retina; Embolism	Procedure: diagnostic cardiac catheterization; Procedure: therapeutic cardiac catheterization	N/A

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 Design

• Study Type: Interventional
• 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: Oct 1, 2009
• Actual Primary Completion Date: May 1, 2010
• Actual Study Completion Date: May 1, 2010

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 52 Years to 68 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	shiraz University of medical sciences	Shiraz	Fars	Iran, Islamic Republic of	55318

Sponsors and Collaborators

• Shiraz University of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01157338
• Other Study ID Numbers: 1123
• First Posted: Jul 7, 2010
• Last Update Posted: Jul 7, 2010
• Last Verified: Jul 1, 2010

• Keywords provided by , ,: Catheter; coronary artery disease; embolus; stroke; retinal emboli
• Additional relevant MeSH terms: Embolism

Study Results

No Results Posted as of Jul 7, 2010