COVID-19COVUSINCT04542083
Covid-19, Acute Myocardial Infarctions and Strokes in France
An observational study of COVID-19 and Acute Cardiovascular Condition, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The COVID-19 pandemic has had dramatic effects on health systems and on non-COVID health care. Using French inpatient claims data and retrospectively collected clinical data, the investigators will assess the changes in hospital admissions for acute cardiovascular and neurovascular conditions in France during and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Acute Cardiovascular Condition, Acute Neurovascular Condition
- How many people
- 911 participants
- Where
- 1 siteFrance
- Study dates
- 20 Sep 2021to 25 Jul 2023
- 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: General population
Who may be able to join
- Adults admitted in 2018, 2019 or 2020 in a French hospital for acute coronary syndrom or stroke
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of COVID-19 on Unplanned Admissions for Acute Cardiovascular and Neurovascular Conditions in France
The COVID-19 pandemic has had dramatic effects on health systems and on non-COVID health care.
Using French inpatient claims data and retrospectively collected clinical data, the investigators will assess the changes in hospital admissions for acute cardiovascular and neurovascular conditions in France during and after the national lockdown.
- Conditions
- COVID-19, Acute Cardiovascular Condition, Acute Neurovascular Condition, Stroke, Acute Myocardial Infarction
- Medical subject headings
- COVID-19, Stroke
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 |
|---|---|---|
| COVID-19 period | Admissions from January to December 2020 | |
| Control period | Admissions from January 2018 to December 2019 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily number of admissions for acute cardio- and neurivascular conditions in France.
Daily number of admissions for acute cardio- and neurivascular conditions in France.
Measured: 1 day
Secondary outcomes (1)
Specific mortality rate.
Specific mortality rate.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start20 Sep 2021
- Primary completion25 Jul 2023
- Study completion25 Jul 2023
Why it stopped: Maximum recruitment reached
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 911 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Grégoire Mercier, PU PH, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04542083
- Sponsor's protocol ID
- RECHMPL20_0513
- Acronym
- COVUSI
- Status last verified
- Aug 2023
- First submitted
- 4 Sep 2020
- Last updated
- 16 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of COVID-19 on Unplanned Admissions for Acute Cardiovascular and Neurovascular Conditions in France
- ClinicalTrials.gov ID
- NCT04542083
- Acronym / sponsor ID
- COVUSI / RECHMPL20_0513
- Conditions
- COVID-19, Acute Cardiovascular Condition, Acute Neurovascular Condition, Stroke, Acute Myocardial Infarction
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Maximum recruitment reached
- Enrolment
- 911 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 25 Jul 2023 (actual)
- Study completion
- 25 Jul 2023 (actual)
- First posted
- 9 Sep 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 has had dramatic effects on health systems and on non-COVID health care.
Using French inpatient claims data and retrospectively collected clinical data, the investigators will assess the changes in hospital admissions for acute cardiovascular and neurovascular conditions in France during and after the national lockdown.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID-19 period | – | –Admissions from January to December 2020 |
| Control period | – | –Admissions from January 2018 to December 2019 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- General population
Key inclusion criteria (1 listed)
- Adults admitted in 2018, 2019 or 2020 in a French hospital for acute coronary syndrom or stroke
Key exclusion criteria (1 listed)
- None
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
Daily number of admissions for acute cardio- and neurivascular conditions in France.
Time frame: 1 day
Daily number of admissions for acute cardio- and neurivascular conditions in France.
1 secondary outcome
Specific mortality rate.
Time frame: 1 day
Results and safety
The study was stopped early (reason given: Maximum recruitment reached). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
- Individual participant dataSharing planned: Undecided. NC
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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.
Grégoire Mercier, PU PH principal investigator
University Hospital, Montpellier
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 COVID-19 and Acute Cardiovascular Condition, run by University Hospital, Montpellier 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: stopped early, as of the sponsor's last update on 16 Aug 2023. 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 was stopped early (reason given: Maximum recruitment reached). Results are not available in the source record.
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?
Daily number of admissions for acute cardio- and neurivascular conditions in France. (time frame: 1 day). 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 16 Aug 2023.