NCT01157338

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 7, 2010

Completed
Last Updated

July 7, 2010

Status Verified

July 1, 2010

Enrollment Period

7 months

First QC Date

July 6, 2010

Last Update Submit

July 6, 2010

Conditions

Keywords

Cathetercoronary artery diseaseembolusstrokeretinal emboli

Outcome Measures

Primary Outcomes (1)

  • retinal emboli

    retinal emboli detected by retinal especialist by direct examination

Secondary Outcomes (2)

  • visual field

  • visual acuity

Study Arms (2)

diagnostic cardiac catheterization

ACTIVE COMPARATOR

patients with diagnostic cardiac catheterization

Procedure: diagnostic cardiac catheterization

therapeutic cardiac catheterization

ACTIVE COMPARATOR

patient with angioplasty

Procedure: therapeutic cardiac catheterization

Interventions

coronary intervention: angiography

diagnostic cardiac catheterization

cardiac catheterization: angioplasty

therapeutic cardiac catheterization

Eligibility Criteria

Age52 Years - 68 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • every patient with diagnostic and therapeutic cardiac catheterization

You may not qualify if:

  • patient refusal to follow up ophthalmology
  • abscence of coronary disease in angiogram
  • abnormal retinal angiogram prior to study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

shiraz University of medical sciences

Shiraz, Fars, 55318, Iran

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

EmbolismCoronary Artery DiseaseStroke

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesArteriosclerosisArterial Occlusive DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 6, 2010

First Posted

July 7, 2010

Study Start

October 1, 2009

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

July 7, 2010

Record last verified: 2010-07

Locations