Stroke, AcuteStroke-Covid19NCT04370197
Covid-19 Epidemic on Acute Stroke Management
An observational study of Stroke, Acute, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The Covid-19 pandemic is a pandemic of an emerging infectious disease, coronavirus 2019 (Covid-19), caused by the coronavirus SARS-CoV-2. It appears in November 2019 in the city of Wuhan, China, and spreads worldwide from February 2020. The first cases of infection in France were confirmed on 24 January 2020. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 3 Mar 2020to 30 Apr 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult stroke patients
Who may be able to join
- Adult patient
- Stroke Patients
- Patient who agreed to participate in this study
Who cannot join
- Refusal to participate in this study
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Neuroradiologie Interventionnelle
Strasbourg, 67091
Rémy BEAUJEUX, MD, PhD, 33 3 88 12 78 71, remy.beaujeux@chru-strasbourg.fr
Raoul POP, MD, 33 3 88 12 78 71, raoul.pop@chru-strasbourg.fr
About this study
Official title: Impact of th Covid-19 Epidemic on Acute Stroke Management
The Covid-19 pandemic is a pandemic of an emerging infectious disease, coronavirus 2019 (Covid-19), caused by the coronavirus SARS-CoV-2. It appears in November 2019 in the city of Wuhan, China, and spreads worldwide from February 2020. The first cases of infection in France were confirmed on 24 January 2020. As of April 14, 103,573 cases of infection were confirmed, 32,292 hospitalized cases, including 6,730 in intensive care, with 15,729 deaths recorded1. The most affected regions are Ile de France and the Grand Est (in particular the Haut-Rhin department). Containment of the entire French population was introduced on 17 March, with the aim of reducing the spread of the virus and relieving the burden on the health system, particularly the intensive care units.
This unprecedented health crisis, as well as the social containment measures in themselves, has repercussions on other acute medical pthologies, not directly related to the viral infection. It appears that the number of patients treated for acute stroke has suddenly declined since the beginning of the epidemic.
However, it is not clear whether it is the incidence of stroke that has declined or simply the proportion of patients presenting within the time frame that allows for treatment in the acute phase (by thrombolysis or thrombectomy).
- Conditions
- Stroke, Acute
- Keywords
- STROKE , Acute, Covid-19, SARS-COV-2, Mechanical thrombectomy, Thrombolysis
- Medical subject headings
- Stroke, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Study of the effect of pandemic covid-19 on the management of stroke patients
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start3 Mar 2020
- Primary completion30 Apr 2020 (estimated)
- Study completion30 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Case only
- Time perspective
- Other
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04370197
- Sponsor's protocol ID
- 7826
- Acronym
- Stroke-Covid19
- Status last verified
- Apr 2020
- First submitted
- 29 Apr 2020
- Last updated
- 30 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of th Covid-19 Epidemic on Acute Stroke Management
- ClinicalTrials.gov ID
- NCT04370197
- Acronym / sponsor ID
- Stroke-Covid19 / 7826
- Conditions
- Stroke, Acute
- Keywords
- STROKE , Acute, Covid-19, SARS-COV-2, Mechanical thrombectomy, Thrombolysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 3 Mar 2020 (actual)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 30 Apr 2020 (estimated)
- First posted
- 30 Apr 2020 (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.
The Covid-19 pandemic is a pandemic of an emerging infectious disease, coronavirus 2019 (Covid-19), caused by the coronavirus SARS-CoV-2. It appears in November 2019 in the city of Wuhan, China, and spreads worldwide from February 2020. The first cases of infection in France were confirmed on 24 January 2020. As of April 14, 103,573 cases of infection were confirmed, 32,292 hospitalized cases, including 6,730 in intensive care, with 15,729 deaths recorded1. The most affected regions are Ile de France and the Grand Est (in particular the Haut-Rhin department). Containment of the entire French population was introduced on 17 March, with the aim of reducing the spread of the virus and relieving the burden on the health system, particularly the intensive care units.
This unprecedented health crisis, as well as the social containment measures in themselves, has repercussions on other acute medical pthologies, not directly related to the viral infection. It appears that the number of patients treated for acute stroke has suddenly declined since the beginning of the epidemic.
However, it is not clear whether it is the incidence of stroke that has declined or simply the proportion of patients presenting within the time frame that allows for treatment in the acute phase (by thrombolysis or thrombectomy).
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult stroke patients
Key inclusion criteria (3 listed)
- Adult patient
- Stroke Patients
- Patient who agreed to participate in this study
Key exclusion criteria (1 listed)
- Refusal to participate in this study
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
Study of the effect of pandemic covid-19 on the management of stroke patients
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2020.
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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.
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 Stroke, Acute, run by University Hospital, Strasbourg, France 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 3 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: status not confirmed, as of the sponsor's last update on 30 Apr 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rémy BEAUJEUX, MD, PhD (33 3 88 12 78 71, remy.beaujeux@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study of the effect of pandemic covid-19 on the management of stroke patients (time frame: 1 month). 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 30 Apr 2020.