NCT04979208

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9,218

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 9, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 9, 2021

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

July 22, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 28, 2021

Completed
Last Updated

August 11, 2021

Status Verified

August 1, 2021

Enrollment Period

12 months

First QC Date

July 22, 2021

Last Update Submit

August 3, 2021

Conditions

Keywords

StrokeAcute Myocardial InfarctionCoronavirus Disease 2019Health OrganizationHealth InequalitiesHealthcare pathway

Outcome Measures

Primary Outcomes (2)

  • Delay for AMI patient

    Delay between the first medical contact and the procedure (coronary angiography or Percutaneous Coronary Intervention)

    At inclusion in the cohort during the acute episode

  • Delay for stroke patient

    Delay between the admission to hospital and the imagery

    At inclusion in the cohort during the acute episode

Study Arms (2)

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).

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients managed between January 1st 2019 and August 31 2020, by emergency units in Aquitaine for an AMI or a recent stroke

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Bordeaux

Bordeaux, 33 076, France

Location

Related Publications (2)

  • 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.

  • Lesaine 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 Links

MeSH Terms

Conditions

COVID-19Stroke

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2021

First Posted

July 28, 2021

Study Start

July 15, 2020

Primary Completion

July 9, 2021

Study Completion

July 9, 2021

Last Updated

August 11, 2021

Record last verified: 2021-08

Locations