Clinical Significance of Retinal Emboli During Diagnostic and Therapeutic Cardiac Catheterization

This study has been completed.
Sponsor:
Information provided by:
Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01157338
First received: July 6, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted
  Purpose

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 Intervention
Cardiac Catheterization
Retina
Embolism
Procedure: diagnostic cardiac catheterization
Procedure: therapeutic cardiac catheterization

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Clinical Significance of Retinal Emboli During Diagnostic and Therapeutic Cardiac Catheterization

Further study details as provided by Shiraz University of Medical Sciences:

Primary Outcome Measures:
  • retinal emboli [ Designated as safety issue: Yes ]
    retinal emboli detected by retinal especialist by direct examination


Secondary Outcome Measures:
  • visual field [ Designated as safety issue: Yes ]
    visual field detected by ophthalmologist

  • visual acuity [ Designated as safety issue: Yes ]
    snellen chart by ophthalmologist


Enrollment: 300
Study Start Date: October 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   52 Years to 68 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Shiraz University of Medical Sciences

Additional 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
Study First Received: July 6, 2010
Last Updated: July 6, 2010
Health Authority: Iran: National health institute

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

ClinicalTrials.gov processed this record on April 17, 2014