Acute Coronary SyndromeCCU-COVID19NCT04344912
Impact of COVID19 Outbreak in Cardiac Acute Care
An observational study of Acute Coronary Syndrome and Heart Failure, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
This registry will evaluate the impact of the COVID19 outbreak on Cardiac patients admitted in the Intensive Care Unit of the Pitie-Salpetriere Hospital in Paris, France Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Heart Failure, COVID
- What is being tested?
- Data collection
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 20 Mar 2020to Dec 2024
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: All patients treated in the CCU at Cardiology Institute of the Pitié-Salpêtrière Hospital, from Friday, March 20, 2020
Who may be able to join
- 18 years and older
- Admitted in the Cardiac Intensive Care Unit from March 20th 2020
- Patient informed and having expressed his non-opposition to participate in the research
Who cannot join
- Minor patient
- Patient who expressed opposition to participation in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Unité de Soins Intensifs de Cardiologie, Pitié Salpêtrière Hospital, AP-HP
Paris, 75013
Johanne SILVAIN, MD PhD, +33142162961, johanne.silvain@aphp.fr
About this study
Official title: Impact of COVID19 Outbreak in Cardiac Patients Admitted in Intensive Care Unit : the CCU-COVID19 Study
This registry will evaluate the impact of the COVID19 outbreak on Cardiac patients admitted in the Intensive Care Unit of the Pitie-Salpetriere Hospital in Paris, France
Read the detailed description
Registry on Characteristics and outcomes of Cardiac patients (COVID- and COVID+) hospitalized in the Intensive Care Unit of the Pitie-Salpetriere Hospital in Paris, France
- Conditions
- Acute Coronary Syndrome, Heart Failure, COVID
- Being tested
- Data collection
- Keywords
- COVID19, Acute Coronary Syndrome, Myocardial Infarction
- Medical subject headings
- Acute Coronary Syndrome, Heart Failure, COVID-19, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Diagnostic and prognostic evaluation of cardiac patients hospitalized in CCU during the COVID-19 outbreak; patient's immune status regarding the presence of SARS-CoV-2 specific antibodies
| Study group | Role | What they receive |
|---|---|---|
| COVID19- Population | Patients without diagnosis of COVID19, as assessed by RT-PCR and CT scan Receives: Other: Data collection | |
| COVID19+ Population | Patients with a diagnosis of COVID19, as assessed by RT-PCR and CT scan Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of recurrent Major Cardiovascular Events (MACE) and urgent rehospitalization
Measured: From admission to one year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start20 Mar 2020
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Other
- Enrolment
- 500 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Action, France
- Responsible party
- Sponsor
- Investigators
- Johanne SILVAIN, MD PhD, Study director, Sorbonne University, ACTION Group, AP-HP Pitié-Salpêtrière Hospital Paris FranceGilles MONTALESCOT, MD PhD, Study chair, Sorbonne University, ACTION Group, AP-HP Pitié-Salpêtrière Hospital Paris France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04344912
- Sponsor's protocol ID
- APHP200524
- Other IDs
- 0522070420
- Acronym
- CCU-COVID19
- Status last verified
- Oct 2024
- First submitted
- 10 Apr 2020
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Open to collaboration
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of COVID19 Outbreak in Cardiac Patients Admitted in Intensive Care Unit : the CCU-COVID19 Study
- ClinicalTrials.gov ID
- NCT04344912
- Acronym / sponsor ID
- CCU-COVID19 / APHP200524
- Conditions
- Acute Coronary Syndrome, Heart Failure, COVID
- Keywords
- COVID19, Acute Coronary Syndrome, Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Action, France
- Study start
- 20 Mar 2020 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 14 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.
This registry will evaluate the impact of the COVID19 outbreak on Cardiac patients admitted in the Intensive Care Unit of the Pitie-Salpetriere Hospital in Paris, France
Detailed description
Registry on Characteristics and outcomes of Cardiac patients (COVID- and COVID+) hospitalized in the Intensive Care Unit of the Pitie-Salpetriere Hospital in Paris, France
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COVID19- Population | – | Other: Data collectionPatients without diagnosis of COVID19, as assessed by RT-PCR and CT scan |
| COVID19+ Population | – | Other: Data collectionPatients with a diagnosis of COVID19, as assessed by RT-PCR and CT scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients treated in the CCU at Cardiology Institute of the Pitié-Salpêtrière Hospital, from Friday, March 20, 2020
Key inclusion criteria (3 listed)
- 18 years and older
- Admitted in the Cardiac Intensive Care Unit from March 20th 2020
- Patient informed and having expressed his non-opposition to participate in the research
Key exclusion criteria (2 listed)
- Minor patient
- Patient who expressed opposition to participation in the 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 |
|---|---|---|
| Data collectionDiagnostic and prognostic evaluation of cardiac patients hospitalized in CCU during the COVID-19 outbreak; patient's immune status regarding the presence of SARS-CoV-2 specific antibodies | Other | COVID19+ Population, COVID19- Population |
Primary outcome
Incidence of recurrent Major Cardiovascular Events (MACE) and urgent rehospitalization
Time frame: From admission to one year follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: Yes. Open to collaboration
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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.
Johanne SILVAIN, MD PhD study director
Sorbonne University, ACTION Group, AP-HP Pitié-Salpêtrière Hospital Paris France
Gilles MONTALESCOT, MD PhD study chair
Sorbonne University, ACTION Group, AP-HP Pitié-Salpêtrière Hospital Paris France
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 Acute Coronary Syndrome and Heart Failure, run by Assistance Publique - Hôpitaux de Paris 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 2 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: looking for participants now, as of the sponsor's last update on 15 Oct 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Johanne SILVAIN, MD PhD (+33142162961, johanne.silvain@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of recurrent Major Cardiovascular Events (MACE) and urgent rehospitalization (time frame: From admission to one year follow up). 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 15 Oct 2024; AzTrials last refreshed its copy on 8 Nov 2026.