Cardiac CatheterizationNCT01157338
Clinical Significance of Retinal Emboli During Diagnostic and Therapeutic Cardiac Catheterization
A study testing diagnostic cardiac catheterization and therapeutic cardiac catheterization in people with Cardiac Catheterization and Retina, run by Shiraz University of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 52 to 68 years
- Conditions the study is for
- Cardiac Catheterization, Retina, Embolism
- What is being tested?
- diagnostic cardiac catheterization and therapeutic cardiac catheterization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteIran
- Study dates
- Oct 2009to May 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 52 to 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- every patient with diagnostic and therapeutic cardiac catheterization
Who cannot join
- patient refusal to follow up ophthalmology
- abscence of coronary disease in angiogram
- abnormal retinal angiogram prior to study
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cardiac Catheterization, Retina, Embolism
- Being tested
- diagnostic cardiac catheterization, therapeutic cardiac catheterization
- Keywords
- Catheter, coronary artery disease, embolus, stroke, retinal emboli
- Medical subject headings
- Embolism, Coronary Artery Disease, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diagnostic cardiac catheterizationProcedure or surgery
coronary intervention: angiography
therapeutic cardiac catheterizationProcedure or surgery
cardiac catheterization: angioplasty
| Study group | Role | What they receive |
|---|---|---|
| diagnostic cardiac catheterization | Active comparator | patients with diagnostic cardiac catheterization Receives: Procedure: diagnostic cardiac catheterization |
| therapeutic cardiac catheterization | Active comparator | patient with angioplasty Receives: Procedure: therapeutic cardiac catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
retinal emboli
retinal emboli detected by retinal especialist by direct examination
Secondary outcomes (2)
visual field
visual field detected by ophthalmologist
visual acuity
snellen chart by ophthalmologist
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2010 (estimated)
- Study startOct 2009
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac CatheterizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01157338
- Sponsor's protocol ID
- 1123
- Status last verified
- Jul 2010
- First submitted
- 6 Jul 2010
- Last updated
- 7 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21255443
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Significance of Retinal Emboli During Diagnostic and Therapeutic Cardiac Catheterization
- ClinicalTrials.gov ID
- NCT01157338
- Acronym / sponsor ID
- 1123
- Conditions
- Cardiac Catheterization, Retina, Embolism
- Keywords
- Catheter, coronary artery disease, embolus, stroke, retinal emboli
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 7 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| diagnostic cardiac catheterization | Active comparator | Procedure: diagnostic cardiac catheterizationpatients with diagnostic cardiac catheterization |
| therapeutic cardiac catheterization | Active comparator | Procedure: therapeutic cardiac catheterizationpatient with angioplasty |
Who may qualify
- Ages
- 52 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- every patient with diagnostic and therapeutic cardiac catheterization
Key exclusion criteria (3 listed)
- patient refusal to follow up ophthalmology
- abscence of coronary disease in angiogram
- abnormal retinal angiogram prior to study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diagnostic cardiac catheterizationcoronary intervention: angiography | Procedure or surgery | diagnostic cardiac catheterization |
| therapeutic cardiac catheterizationcardiac catheterization: angioplasty | Procedure or surgery | therapeutic cardiac catheterization |
Primary outcome
retinal emboli
retinal emboli detected by retinal especialist by direct examination
2 secondary outcomes
visual field
visual acuity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2010.
- Derived from this study: PubMed 21255443Kojuri 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diagnostic cardiac catheterization and therapeutic cardiac catheterization in people with Cardiac Catheterization and Retina, run by Shiraz University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
retinal emboli. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01157338, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2010.