Coronavirus Disease 2019AVICOVIDNCT04979208
Impact of Changes in the Use of Care and Reorganization of the Healthcare System Linked to the Covid-19 Outbreak on the Quality of Care Pathways of Patients Suffering From Acute Myocardial Infarction and Stroke in Aquitaine (AVICOVID)
An observational study of Coronavirus Disease 2019 and Stroke, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
The Covid-19 pandemic and its health and societal consequences raise fears of a deterioration in the management of non-Covid-19 pathologies, particularly those requiring rapid treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronavirus Disease 2019, Stroke, Acute Myocardial Infarction
- How many people
- 9,218 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jul 2020to 9 Jul 2021
- 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
- Adult, Older adult
Study population: Patients managed between January 1st 2019 and August 31 2020, by emergency units in Aquitaine for an AMI or a recent stroke
Who may be able to join
- Patients over 18 years, domiciled in metropolitan France
- Patients managed between January 1st 2019 and August 31 2020, by emergency units in Aquitaine for AMI
- Patients managed between January 1st 2019 and August 31 2020, by emergency units in Aquitaine for recent stroke
Who cannot join
- AMI cohort :
- Patient with pacemaker;
- Patients in cardiac arrest before performing the first qualifying ECG.
- Stroke cohort :
- Patients treated for sequelae rehabilitation, complications of a recent stroke, transient ischemic accident or any other neurological pathology
- Both :
- Patients who refused to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Changes in the Use of Care and Reorganization of the Healthcare System Linked to the Covid-19 Outbreak on the Quality of Care Pathways of Patients Suffering From Acute Myocardial Infarction and Stroke in the Aquitaine Region
The Covid-19 pandemic and its health and societal consequences raise fears of a deterioration in the management of non-Covid-19 pathologies, particularly those requiring rapid treatment. These fears relate in particular to strokes and acute myocardial infarctions (AMI), the two most frequent diseases, for which emergency treatment is a major factor in the vital and functional prognosis of patients. They are based on activity data from the emergency services, which have shown a sharp drop in admissions for AMI and strokes at the start of the pandemic. This drop is interpreted as being partly linked to a tendency for patients to delay or even give up care, which may be explained by fear of contamination, the desire not to solicit already overworked healthcare professionals and overload in emergency structures. In addition, studies have shown that the time required to treat AMI during the pandemic phase in China has been extended due to the new organizations set up in healthcare institutions in connection with this major health event. In addition, certain inequalities in access to care, already identified during the non- pandemic period among AMI and stroke patients, are likely to be accentuated by the new healthcare organizations set up during the pandemic period.
The investigators are interested in the impact of changes in healthcare utilization and reorganization within hospitals, related to the Covid-19 pandemic, on the quality of the care pathway for stroke and AMI patients in the Aquitaine region. The investigators also study the role of the socio-demographic, socio-economic and geographical characteristics of these patients as factors of inequality of access to care during this period.
Read more
The project is based on data collected within the Aquitaine Cardio-Neuro-Vascular Registries (CNV), an exhaustive cohort of stroke and AMI patients treated by a health care institution in Aquitaine. They are an excellent tool for describing the care pathway and outcomes of these patients, from the onset of symptoms to the end of the acute episode. An additional collection is planned to collect all the organizations and activities set up within the hospitals in Aquitaine. The study period, from January 2019 to August 2020, provides sufficient time before lockdown and after the date of the end of lockdown, to analyze trends in the quality of pathways, according to the various reorganizations of the health system and changes in the use of care linked to the management of the Covid-19 pandemic.
The project identifies the reorganizations with the most striking consequences on the quality of care for patients suffering from non Covid-19 pathologies. It analyzes the changes in the behaviour of patients and their family and caregivers in their use of care during the Covid-19 pandemic and their impact on the care pathways and results. It contributes to the policy of reducing inequalities in access to care and to the definition of a health strategy in the event of a major health crisis.
- Keywords
- Stroke, Acute Myocardial Infarction, Coronavirus Disease 2019, Health Organization, Health Inequalities, Healthcare pathway
- 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 |
|---|---|---|
| Acute myocardial infarction (AMI) cohort | Adult patients with recent acute myocardial infarction admitted to an hospital in the French Aquitaine region between January 1st 2019 and August 31 2020 and included in the ongoing, permanent, multicenter, retrospective and nominative ObA2 and REANIM/ACIRA registries. Were included in the analysis all recent AMI patients less than 24 hours old diagnosed by emergency physicians on the basis of suggestive clinical symptoms and electrocardiogram (ECG) criteria, cared in the 30 emergency units and 19 mobil intensive care unit, with a coronary angiography or a percutaneous coronary intervention (PCI) realized in the 11 cathlabs in Aquitaine | |
| Stroke cohort | Adult patients with recent stroke admitted to an hospital in the French Aquitaine region between January 1st 2019 and August 31 2020 and included in the ongoing, permanent, multicenter, retrospective and nominative ObA2 and REANIM/ACIRA registries. Were included in the analysis recent ischemic or hemorragic stroke patients with brain imaging managed in one of the 14 participating hospitals in Aquitaine (7 stroke units and 7 primary care centers). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delay for AMI patient
Delay between the first medical contact and the procedure (coronary angiography or Percutaneous Coronary Intervention)
Measured: At inclusion in the cohort during the acute episode
Delay for stroke patient
Delay between the admission to hospital and the imagery
Measured: At inclusion in the cohort during the acute episode
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start15 Jul 2020
- Primary completion9 Jul 2021
- Study completion9 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronavirus Disease 2019Studies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Retrospective
- Enrolment
- 9,218 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04979208
- Sponsor's protocol ID
- CHUBX 2020/39
- Acronym
- AVICOVID
- Status last verified
- Aug 2021
- First submitted
- 22 Jul 2021
- Last updated
- 11 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lesaine E, Francis F, Domecq S, Miganeh-Hadi S, Sevin F, Sibon I, Rouanet F, Pradeau C, Coste P, Cetran L, Vandentorren S, Saillour F; AVICOVID group. Social and clinical vulnerability in stroke and STEMI management during the COVID-19 pandemic: a registry-based study. BMJ Open. 2024 Jan 3;14(1):e073933. doi: 10.1136/bmjopen-2023-073933.
PubMed 38171619Lesaine E, Francis-Oliviero F, Domecq S, Bijon M, Cetran L, Coste P, Lhuaire Q, Miganeh-Hadi S, Pradeau C, Rouanet F, Sevin F, Sibon I, Saillour-Glenisson F; AVICOVID group. Effects of healthcare system transformations spurred by the COVID-19 pandemic on management of stroke and STEMI: a registry-based cohort study in France. BMJ Open. 2022 Sep 21;12(9):e061025. doi: 10.1136/bmjopen-2022-061025.
PubMed 36130741
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Changes in the Use of Care and Reorganization of the Healthcare System Linked to the Covid-19 Outbreak on the Quality of Care Pathways of Patients Suffering From Acute Myocardial Infarction and Stroke in the Aquitaine Region
- ClinicalTrials.gov ID
- NCT04979208
- Acronym / sponsor ID
- AVICOVID / CHUBX 2020/39
- Keywords
- Stroke, Acute Myocardial Infarction, Coronavirus Disease 2019, Health Organization, Health Inequalities, Healthcare pathway
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,218 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 9 Jul 2021 (actual)
- Study completion
- 9 Jul 2021 (actual)
- First posted
- 28 Jul 2021 (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 and its health and societal consequences raise fears of a deterioration in the management of non-Covid-19 pathologies, particularly those requiring rapid treatment. These fears relate in particular to strokes and acute myocardial infarctions (AMI), the two most frequent diseases, for which emergency treatment is a major factor in the vital and functional prognosis of patients. They are based on activity data from the emergency services, which have shown a sharp drop in admissions for AMI and strokes at the start of the pandemic. This drop is interpreted as being partly linked to a tendency for patients to delay or even give up care, which may be explained by fear of contamination, the desire not to solicit already overworked healthcare professionals and overload in emergency structures. In addition, studies have shown that the time required to treat AMI during the pandemic phase in China has been extended due to the new organizations set up in healthcare institutions in connection with this major health event. In addition, certain inequalities in access to care, already identified during the non- pandemic period among AMI and stroke patients, are likely to be accentuated by the new healthcare organizations set up during the pandemic period.
The investigators are interested in the impact of changes in healthcare utilization and reorganization within hospitals, related to the Covid-19 pandemic, on the quality of the care pathway for stroke and AMI patients in the Aquitaine region. The investigators also study the role of the socio-demographic, socio-economic and geographical characteristics of these patients as factors of inequality of access to care during this period.
The project is based on data collected within the Aquitaine Cardio-Neuro-Vascular Registries (CNV), an exhaustive cohort of stroke and AMI patients treated by a health care institution in Aquitaine. They are an excellent tool for describing the care pathway and outcomes of these patients, from the onset of symptoms to the end of the acute episode. An additional collection is planned to collect all the organizations and activities set up within the hospitals in Aquitaine. The study period, from January 2019 to August 2020, provides sufficient time before lockdown and after the date of the end of lockdown, to analyze trends in the quality of pathways, according to the various reorganizations of the health system and changes in the use of care linked to the management of the Covid-19 pandemic.
The project identifies the reorganizations with the most striking consequences on the quality of care for patients suffering from non Covid-19 pathologies. It analyzes the changes in the behaviour of patients and their family and caregivers in their use of care during the Covid-19 pandemic and their impact on the care pathways and results. It contributes to the policy of reducing inequalities in access to care and to the definition of a health strategy in the event of a major health crisis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute myocardial infarction (AMI) cohort | – | –Adult patients with recent acute myocardial infarction admitted to an hospital in the French Aquitaine region between January 1st 2019 and August 31 2020 and included in the ongoing, permanent, multicenter, retrospective and nominative ObA2 and REANIM/ACIRA registries. Were included in the analysis all recent AMI patients less than 24 hours old diagnosed by emergency physicians on the basis of suggestive clinical symptoms and electrocardiogram (ECG) criteria, cared in the 30 emergency units and 19 mobil intensive care unit, with a coronary angiography or a percutaneous coronary intervention (PCI) realized in the 11 cathlabs in Aquitaine |
| Stroke cohort | – | –Adult patients with recent stroke admitted to an hospital in the French Aquitaine region between January 1st 2019 and August 31 2020 and included in the ongoing, permanent, multicenter, retrospective and nominative ObA2 and REANIM/ACIRA registries. Were included in the analysis recent ischemic or hemorragic stroke patients with brain imaging managed in one of the 14 participating hospitals in Aquitaine (7 stroke units and 7 primary care centers). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients managed between January 1st 2019 and August 31 2020, by emergency units in Aquitaine for an AMI or a recent stroke
Key inclusion criteria (3 listed)
- Patients over 18 years, domiciled in metropolitan France
- Patients managed between January 1st 2019 and August 31 2020, by emergency units in Aquitaine for AMI
- Patients managed between January 1st 2019 and August 31 2020, by emergency units in Aquitaine for recent stroke
Key exclusion criteria (7 listed)
- Patient with pacemaker;
- Patients in cardiac arrest before performing the first qualifying ECG.
- Patients treated for sequelae rehabilitation, complications of a recent stroke, transient ischemic accident or any other neurological pathology
- Patients who refused to participate
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
Delay for AMI patient
Time frame: At inclusion in the cohort during the acute episode
Delay between the first medical contact and the procedure (coronary angiography or Percutaneous Coronary Intervention)
Delay for stroke patient
Time frame: At inclusion in the cohort during the acute episode
Delay between the admission to hospital and the imagery
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 11 Aug 2021.
- Derived from this study: PubMed 38171619Lesaine E, Francis F, Domecq S, Miganeh-Hadi S, Sevin F, Sibon I, Rouanet F, Pradeau C, Coste P, Cetran L, Vandentorren S, Saillour F; AVICOVID group. Social and clinical vulnerability in stroke and STEMI management during the COVID-19 pandemic: a registry-based study. BMJ Open. 2024 Jan 3;14(1):e073933. doi: 10.1136/bmjopen-2023-073933.
- Derived from this study: PubMed 36130741Lesaine E, Francis-Oliviero F, Domecq S, Bijon M, Cetran L, Coste P, Lhuaire Q, Miganeh-Hadi S, Pradeau C, Rouanet F, Sevin F, Sibon I, Saillour-Glenisson F; AVICOVID group. Effects of healthcare system transformations spurred by the COVID-19 pandemic on management of stroke and STEMI: a registry-based cohort study in France. BMJ Open. 2022 Sep 21;12(9):e061025. doi: 10.1136/bmjopen-2022-061025.
- Related InfoLink provided by the sponsor.
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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.
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 Coronavirus Disease 2019 and Stroke, run by University Hospital, Bordeaux 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 7 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 11 Aug 2021. 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?
Delay for AMI patient (time frame: At inclusion in the cohort during the acute episode). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04979208, which also lists 2 linked publications.
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 11 Aug 2021.