Clinical Significance of Retinal Emboli During Diagnostic... | NCT01157338

Studies
Clinical Significance of Retinal Emboli During Diagnostic and Therapeutic Cardiac Catheterization

NCT01157338

Sponsor

Shiraz University of Medical Sciences

Status

Completed

Last Update Posted

Jul 7, 2010Estimated

Enrollment

300Actual

Phase

Not Applicable

Conditions

Cardiac Catheterization
Retina
Embolism

Interventions

diagnostic cardiac catheterization
therapeutic cardiac catheterization

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

May 2010Actual

Completion Date

May 2010Actual

First Submitted Date

Jul 6, 2010

First Submission Date that Met QC Criteria

Jul 6, 2010

First Posted Date

Jul 7, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 6, 2010

Last Update Posted Date

Jul 7, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
diagnostic cardiac catheterization	Procedure	coronary intervention: angiography	diagnostic cardiac catheterization

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
retinal emboli	retinal emboli detected by retinal especialist by direct examination

Secondary Outcomes

Measure	Description	Time Frame
visual field	visual field detected by ophthalmologist
visual acuity	snellen chart by ophthalmologist

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

52 Years

Maximum Age

68 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
shiraz University of medical sciences		Shiraz	Fars	55318	Iran

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21255443	Derived	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.

ID	Term
D004617	Embolism
D003324	Coronary Artery Disease
D020521	Stroke

ID	Term
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D003327	Coronary Disease