Life Threatening DiseasesNCT03078387
The Extreme Significance of Bilateral Embolic Retinal Phenomena That Can be Life Saving
An observational study of Life Threatening Diseases and Embolic Shower, run by Dr. Shawkat Michel at 1 site in Canada.
Trial summary
This study shows how careful ophthalmic examination of two patients showed signs of simultaneous bilateral retinal emboli. Starting from this point significant, life threatening, underlying reasons were found and treated. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Life Threatening Diseases, Embolic Shower
- What is being tested?
- imaging
- How many people
- 2 participants
- Where
- 1 siteCanada
- Study dates
- 31 Aug 2006to 31 Dec 2018
- Phase
- Observational
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: any patient in which signs of bilateral retinal emboli are seen and documented (imaged).
Who may be able to join
- any patient who is found to have sure signs of bilateral retinal emboli.
Who cannot join
- all other bilateral retinal diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bilateral Retinal Embolic Phenomena Always Necessitates Immediate and Intensive Investigation. Careful, Documented, Ophthalmic Examination is All we Require to Initiate Life Saving Investigations.
This study shows how careful ophthalmic examination of two patients showed signs of simultaneous bilateral retinal emboli. Starting from this point significant, life threatening, underlying reasons were found and treated.
Read the detailed description
Two patients were found to have signs of simultaneous bilateral retinal emboli. One patient was asymptomatic and routine ophthalmic examination showed bilateral retinal hemorrhages and exudates close to both optic discs. This patient was on anti-coagulant treatment for atrial fibrillation. The finding of bilateral signs of retinal emboli necessitated immediate blood tests and dose adjustments of her medication.
The second case did not have general symptoms other than mild evening chills and her eye examination again was the start point of intensive investigation to find the reason of her bilateral retinal emboli. Ultrasound studies revealed a life threatening reason that was urgently treated.
- Conditions
- Life Threatening Diseases, Embolic Shower
- Being tested
- imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
imagingDiagnostic test
Also called color fundus photos
imaging before and after treatment
What is being measured
The primary outcome is the main question the study is designed to answer.
The extreme significance of immediate investigation of cases of bilateral retinal emboli (non-diabetic bilateral posterior pole retinal nerve fiber or pre-retinal hemorrhages).
Patients that are noticed to have signs of bilateral retinal emboli (bilateral retinal nerve fiber layer hemorrhages or bilateral pre-retinal hemorrhages and sometimes bilateral soft exudates) may be asymptomatic or have very mild symptoms. However these patients must be immediately and, if needed, intensively investigated to find the source of these emboli. The extremely important point of this study is these patients usually have life threatening conditions that should be found out and treated in time.
Measured: through study completion, an average of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2017
- Study start31 Aug 2006
- Primary completion29 Jan 2013
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Life Threatening DiseasesStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Shawkat Michel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Shawkat Michel, Dr. S.S. Michel Clinic
- Investigators
- shawkat s. Michel, MD, FRCS Ed, Principal investigator, Dr. S.S. Michel Clinic, 214 MHC, 156 street and 87 Ave, Edmonton, AB, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03078387
- Sponsor's protocol ID
- Bilateral retinal emboli
- Status last verified
- Apr 2019
- First submitted
- 6 Mar 2017
- Last updated
- 4 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Color photographs of patients with bilateral retinal emboli and relevant medical conditions will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral Retinal Embolic Phenomena Always Necessitates Immediate and Intensive Investigation. Careful, Documented, Ophthalmic Examination is All we Require to Initiate Life Saving Investigations.
- ClinicalTrials.gov ID
- NCT03078387
- Acronym / sponsor ID
- Bilateral retinal emboli
- Conditions
- Life Threatening Diseases, Embolic Shower
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Dr. Shawkat MichelUniversity, hospital or other
- Study start
- 31 Aug 2006 (actual)
- Primary completion
- 29 Jan 2013 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 13 Mar 2017 (actual)
- 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.
This study shows how careful ophthalmic examination of two patients showed signs of simultaneous bilateral retinal emboli. Starting from this point significant, life threatening, underlying reasons were found and treated.
Detailed description
Two patients were found to have signs of simultaneous bilateral retinal emboli. One patient was asymptomatic and routine ophthalmic examination showed bilateral retinal hemorrhages and exudates close to both optic discs. This patient was on anti-coagulant treatment for atrial fibrillation. The finding of bilateral signs of retinal emboli necessitated immediate blood tests and dose adjustments of her medication.
The second case did not have general symptoms other than mild evening chills and her eye examination again was the start point of intensive investigation to find the reason of her bilateral retinal emboli. Ultrasound studies revealed a life threatening reason that was urgently treated.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- any patient in which signs of bilateral retinal emboli are seen and documented (imaged).
Key inclusion criteria (1 listed)
- any patient who is found to have sure signs of bilateral retinal emboli.
Key exclusion criteria (1 listed)
- all other bilateral retinal diseases.
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 |
|---|---|---|
| imagingAlso: color fundus photosimaging before and after treatment | Diagnostic test | – |
Primary outcome
The extreme significance of immediate investigation of cases of bilateral retinal emboli (non-diabetic bilateral posterior pole retinal nerve fiber or pre-retinal hemorrhages).
Time frame: through study completion, an average of one year
Patients that are noticed to have signs of bilateral retinal emboli (bilateral retinal nerve fiber layer hemorrhages or bilateral pre-retinal hemorrhages and sometimes bilateral soft exudates) may be asymptomatic or have very mild symptoms. However these patients must be immediately and, if needed, intensively investigated to find the source of these emboli. The extremely important point of this study is these patients usually have life threatening conditions that should be found out and treated in time.
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 4 Apr 2019.
- Individual participant dataSharing planned: Yes. Color photographs of patients with bilateral retinal emboli and relevant medical conditions will be shared.
Related trials for Life Threatening Diseases
RecruitingObservational study
Real-Time Diagnosis of Life-Threatening Necrotizing Soft Tissue Infections (NSTI) Using Indocyanine Green (ICG) Kinetic Modeling
Necrotizing Fascitis
RecruitingPhase 1/2
A Study of Zedoresertib (Debio 0123) in Combination With Temozolomide in Adult Participants With Recurrent or Progressive Glioblastoma and of Zedoresertib (Debio 0123) in Combination With Temozolomide and Radiotherapy in Adult Participants With Newly Diagnosed Glioblastoma
Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype, Astrocytoma, Grade III
Not yet recruitingPhase 2
IDH1-vac in Patients With Newly Diagnosed IDH1R132H-positive High-grade Astrocytomas
Astrocytoma, IDH-Mutant, Grade 3, Astrocytoma, IDH-Mutant, Grade 4
RecruitingObservational study
Effect of Thickened Feeds on Clinical Outcomes in Children With Brief Resolved Unexplained Event
Brief Resolved Unexplained Event, Apparent Life Threatening Event
RecruitingPhase 1
Intracranial Genetically Modified Immune Cells (TGFβR2KO/IL13Rα2 CAR T-Cells) for the Treatment of Recurrent or Progressive Glioblastoma or Grade 3 or 4 IDH-Mutant Astrocytoma
Recurrent Astrocytoma, IDH-Mutant, Grade 3, Recurrent Astrocytoma, IDH-Mutant, Grade 4
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.
shawkat s. Michel, MD, FRCS Ed principal investigator
Dr. S.S. Michel Clinic, 214 MHC, 156 street and 87 Ave, Edmonton, AB, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Life Threatening Diseases and Embolic Shower, run by Dr. Shawkat Michel at 1 site in Canada.
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 1 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 4 Apr 2019. 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 Canada. 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?
The extreme significance of immediate investigation of cases of bilateral retinal emboli (non-diabetic bilateral posterior pole retinal nerve fiber or pre-retinal hemorrhages). (time frame: through study completion, an average of one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Apr 2019.