Silent StrokeICEPNCT00831259
Risk of Stroke in Pulmonary Embolism With a Patent Foramen Ovale (PFO)
An observational study of Silent Stroke and Pulmonary Embolism, run by University Hospital, Caen at 1 site in France.
Trial summary
Pulmonary embolism is associated with a small but definite risk of paradoxical embolism in patients with a patent foramen ovale (PFO). While neurologic complications are unfrequent the incidence of clinically silent brain infarction is unknown. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Silent Stroke, Pulmonary Embolism, Patent Foramen Ovale
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2007to May 2009
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive series of patients with a pulmonary embolism
Who may be able to join
- Pulmonary embolism, informed consent signed, no-contraindication to MRI
Who cannot join
- contra-indication to MRI, informed consent not obtained
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Silent Cerebral Infarcts in Patients With Pulmonary Embolism and a Patent Foramen Ovale: a Prospective Diffusion-weighted Magnetic Resonance Imaging Study.
Pulmonary embolism is associated with a small but definite risk of paradoxical embolism in patients with a patent foramen ovale (PFO). While neurologic complications are unfrequent the incidence of clinically silent brain infarction is unknown. We will assess the rate of clinically apparent and silent cerebral embolism in patients with a pulmonary embolism (PE) in relation to the presence or not of a PFO.
- Conditions
- Silent Stroke, Pulmonary Embolism, Patent Foramen Ovale
- Keywords
- stroke, PFO, embolism
- Medical subject headings
- Pulmonary Embolism, Foramen Ovale, Patent, Stroke, Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Incidence of silent stroke in patients with PFO | |
| 2 | Incidence of silent stroke in patients without PFO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of cerebral infarcts as detected by Diffusion-weighted MRI
Measured: during hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2009 (estimated)
- Study startOct 2007
- Primary completionApr 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Silent StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00831259
- Sponsor's protocol ID
- CHU de Caen
- Acronym
- ICEP
- Status last verified
- May 2011
- First submitted
- 27 Jan 2009
- Last updated
- 20 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Silent Cerebral Infarcts in Patients With Pulmonary Embolism and a Patent Foramen Ovale: a Prospective Diffusion-weighted Magnetic Resonance Imaging Study.
- ClinicalTrials.gov ID
- NCT00831259
- Acronym / sponsor ID
- ICEP / CHU de Caen
- Conditions
- Silent Stroke, Pulmonary Embolism, Patent Foramen Ovale
- Keywords
- stroke, PFO, embolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 28 Jan 2009 (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.
Pulmonary embolism is associated with a small but definite risk of paradoxical embolism in patients with a patent foramen ovale (PFO). While neurologic complications are unfrequent the incidence of clinically silent brain infarction is unknown. We will assess the rate of clinically apparent and silent cerebral embolism in patients with a pulmonary embolism (PE) in relation to the presence or not of a PFO.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Incidence of silent stroke in patients with PFO |
| 2 | – | –Incidence of silent stroke in patients without PFO |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive series of patients with a pulmonary embolism
Key inclusion criteria (1 listed)
- Pulmonary embolism, informed consent signed, no-contraindication to MRI
Key exclusion criteria (1 listed)
- contra-indication to MRI, informed consent not obtained
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of cerebral infarcts as detected by Diffusion-weighted MRI
Time frame: during hospitalization
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 20 May 2011.
Related trials for Silent Stroke
Active, not recruitingObservational study
Stroke Prevention in Young Adults With Sickle Cell Anemia
Sickle Cell Disease, Sickle Cell Anemia
Enrolling by invitationObservational study
Federated Learning for Point-of-Care Cardiac Ultrasound
Ventricular Dysfunction, Left, Ventricular Function, Left
Active, not recruitingPhase 4
Efficacy of Clopidogrel on Incidence of Silent Brain Infarction
Silent Brain Infarction
Recruiting
A Standard Carbon Dioxide Flushing Protocol to Reduce Air Embolization During Thoracic Endovascular Aortic Repair
Type B Acute Aortic Syndrome, Thoracic and Thoracoabdominal Aneurysms With Crawford Extent I, II, III, or IV
Active, not recruiting
Multidisciplinary Lifestyle Interventions for Neurological Disorders During the Silent Phase
Neurological Disorder
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?
An observational study of Silent Stroke and Pulmonary Embolism, run by University Hospital, Caen at 1 site in France.
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 20 May 2011. 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 France. 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?
Incidence of cerebral infarcts as detected by Diffusion-weighted MRI (time frame: during hospitalization). 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 20 May 2011.