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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

July 6, 2010
July 6, 2010
October 2009
May 2010   (final data collection date for primary outcome measure)
retinal emboli [ Designated as safety issue: Yes ]
retinal emboli detected by retinal especialist by direct examination
Same as current
No Changes Posted
  • visual field [ Designated as safety issue: Yes ]
    visual field detected by ophthalmologist
  • visual acuity [ Designated as safety issue: Yes ]
    snellen chart by ophthalmologist
Same as current
Not Provided
Not Provided
 
Clinical Significance of Retinal Emboli During Diagnostic and Therapeutic Cardiac Catheterization
Clinical Significance of Retinal Emboli During Diagnostic and Therapeutic Cardiac Catheterization

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Cardiac Catheterization
  • Retina
  • Embolism
  • Procedure: diagnostic cardiac catheterization
    coronary intervention: angiography
  • Procedure: therapeutic cardiac catheterization
    cardiac catheterization: angioplasty
  • Active Comparator: diagnostic cardiac catheterization
    patients with diagnostic cardiac catheterization
    Intervention: Procedure: diagnostic cardiac catheterization
  • Active Comparator: therapeutic cardiac catheterization
    patient with angioplasty
    Intervention: Procedure: therapeutic cardiac catheterization
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
May 2010
May 2010   (final data collection date for primary outcome measure)

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
Both
52 Years to 68 Years
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT01157338
1123
Yes
Dr Javad Kojuri, Shiraz University of medical sciences
Shiraz University of Medical Sciences
Not Provided
Not Provided
Shiraz University of Medical Sciences
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP