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. (MAESTRO)

Association of Metagenomics and Transcriptomics With the Appearance and Evolution of an Ischemic Stroke

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.

Study Overview

• Status: Recruiting
• Conditions: Ischemic Stroke

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Miquel Lledós, MSc; Phone Number: +34679815196; Email: mlledos@santpau.cat

Study Locations

• Spain
  • Barcelona, Spain, 08025
    • Recruiting
    • Institut de Recerca Hospital de la Santa Creu i Sant Pau
    • Contact: Miquel Lledós, MSc; Phone Number: +34679815196; Email: mlledos@santpau.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Control
Ischemic stroke patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risk of stroke and disability after a stroke	Use of the Modified Rankin Scale (mRS), evaluted from 0 to 6 (where higher scores mean worse outcome), to asses disability in patients who have suffered a stroke and comparison over time to check for recovery and degree of continued disability	3 months

Collaborators and Investigators

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Collaborators: Instituto de Salud Carlos III
• Investigators: Principal Investigator: Israel Fernández Cadenas, PhD, Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2020
• Primary Completion (Anticipated): July 15, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: March 10, 2021
• First Submitted That Met QC Criteria: March 10, 2021
• First Posted (Actual): March 12, 2021

Study Record Updates

• Last Update Posted (Actual): September 21, 2021
• Last Update Submitted That Met QC Criteria: September 18, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Stroke; Gut microbiota; Metagenomics
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: IIBSP-MAE-2020-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected individual participant data (IPD).
• IPD Sharing Time Frame: Starting 6 months after publication.
• IPD Sharing Access Criteria: IPD will be shared for further analysis under request. Requests will be reviewed by the overall study official Dr. Israel Fernández Cadenas.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No