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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04979208
Other study ID # CHUBX 2020/39
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 15, 2020
Est. completion date July 9, 2021

Study information

Verified date August 2021
Source University Hospital, Bordeaux
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 9218
Est. completion date July 9, 2021
Est. primary completion date July 9, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: 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

Study Design


Locations

Country Name City State
France CHU Bordeaux Bordeaux

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Delay for stroke patient Delay between the admission to hospital and the imagery At inclusion in the cohort during the acute episode
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