Clinical trial NCT04795687: Discovering Patterns in the Gut Microbiota Associated With the Risk of Stroke and the Outcome After a Stroke and Integration of These Data With Genomic Information to Find New Drug Targets and New Treatments to Improve Neurological Evolution and Functional Status of Stroke Patients.
Official title: Association of Metagenomics and Transcriptomics With the Appearance and Evolution of an Ischemic Stroke
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ischemic Stroke
Keywords: Gut microbiota
Stroke
Metagenomics
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2021-03-12
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Samples will be collected from those patients with ischemic stroke who attend the Hospital de la Santa Creu i Sant Pau while the study is carried out.

Brief summary: The composition of the intestinal microbiota is associated with the risk of stroke and with post-stroke neurological evolution. At the same time, the genetics and epigenetics of each patient are associated with the composition of the intestinal microbiota. The study of the microbiome in stroke patients will allow finding new therapeutic targets for the treatment of stroke patients.

For the study, samples will be collected from those patients with ischemic stroke who come to the hospital while the study is being carried out, taking into account certain criteria: the patients must be over 18 years of age, have suffered an ischemic stroke (demonstrated by resonance or head CT), not have any additional serious illness or unstable medical condition, and not be included in clinical trials with neuroprotective drugs. On the other hand, the control group will be asymptomatic, and will be made up of people who have not previously suffered a stroke or a cardiovascular event and who do not have diseases that affect the digestive tract.

The main variables of the study are the risk of stroke and disability after a cerebrovascular accident (measured by mRS at 3rd month). Microbiota, genetic and epigenetic variables are also taken into account, such as the presence and levels of bacteria, dysbiosis, genetic polymorphisms and levels of methylation in CpG islands.


Eligibility criteria: Inclusion Criteria:

* Patients with ischemic stroke (demonstrated by resonance or head CT).

Exclusion Criteria:

* Patients under 18 years of age.
* Additional serious illness or unstable medical condition.
* Inclusion in clinical trials with neuroprotective drugs.

Primary outcomes:
measure: Risk of stroke and disability after a stroke
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Institut de Recerca Hospital de la Santa Creu i Sant Pau
Study officials:
affiliation: Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Israel Fernández Cadenas, PhD
role: PRINCIPAL_INVESTIGATOR
References: