PET/MR in Post Stroke Cardiac Inflammation Study

NCT ID: NCT05791617

Last Updated: 2024-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-01

Study Completion Date

2025-09-02

Brief Summary

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Patients with stroke have a 25x higher risk of cardiovascular complications within the first 30 days of the event compared to individuals without stroke. The mechanisms behind these complications are not well understood. Evidence suggests that inflammation plays a central role. With the present proof-of-concept prospective cohort study, the investigators aim to demonstrate that patients develop cardiac inflammation after stroke by performing positron emission tomography (PET) magnetic resonance imaging (MRI) of the heart within 15 days after stroke. As a secondary aim, the investigators will evaluate whether post-stroke cardiac inflammation persists at 3 months after stroke. The control group will be comprised of age- and sex-matched individuals without stroke.

Detailed Description

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Conditions

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Stroke Inflammation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cases (Ischemic stroke)

Left and right middle cerebral artery ischemic stroke Patients presenting with acute onset focal neurological deficits and DWI-MRI evidence of an acute brain infarct of the left or right middle cerebral artery ischemic stroke.

cardiac PET/MRI

Intervention Type DIAGNOSTIC_TEST

Patients will undergo cardiac PET/MRI scanning at 30±5 days and at 90±5 days post-stroke.

Inflammatory markers

Intervention Type DIAGNOSTIC_TEST

Measurement of a panel of 92 systemic inflammatory markers on patients' blood samples at 30±5 days and at 90±5 days post-stroke

Diagnostic Test: NT-proBNP

Intervention Type DIAGNOSTIC_TEST

NT-proBNP is useful both in the diagnosis and prognosis of heart failure and is considered to be a gold standard biomarker in heart failure. Measurement of NT-proBNP on patients' blood samples at 30±5 days and at 90±5 days post-stroke

Controls (TIA)

Patients with acute focal neurological symptoms without brain infarct on MRI. Patients presenting with acute onset focal neurological deficits presumed to be of vascular origin, WITHOUT DWI-MRI evidence of an acute brain infarct.

cardiac PET/MRI

Intervention Type DIAGNOSTIC_TEST

Patients will undergo cardiac PET/MRI scanning at 30±5 days and at 90±5 days post-stroke.

Inflammatory markers

Intervention Type DIAGNOSTIC_TEST

Measurement of a panel of 92 systemic inflammatory markers on patients' blood samples at 30±5 days and at 90±5 days post-stroke

Diagnostic Test: NT-proBNP

Intervention Type DIAGNOSTIC_TEST

NT-proBNP is useful both in the diagnosis and prognosis of heart failure and is considered to be a gold standard biomarker in heart failure. Measurement of NT-proBNP on patients' blood samples at 30±5 days and at 90±5 days post-stroke

Interventions

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cardiac PET/MRI

Patients will undergo cardiac PET/MRI scanning at 30±5 days and at 90±5 days post-stroke.

Intervention Type DIAGNOSTIC_TEST

Inflammatory markers

Measurement of a panel of 92 systemic inflammatory markers on patients' blood samples at 30±5 days and at 90±5 days post-stroke

Intervention Type DIAGNOSTIC_TEST

Diagnostic Test: NT-proBNP

NT-proBNP is useful both in the diagnosis and prognosis of heart failure and is considered to be a gold standard biomarker in heart failure. Measurement of NT-proBNP on patients' blood samples at 30±5 days and at 90±5 days post-stroke

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Olink® Target-96 inflammatory biomarker panel N-terminal prohormone of brain natriuretic peptide

Eligibility Criteria

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Inclusion Criteria

* Age ≥18 years willing to cons Age ≥18 years willing to consent
* Patients with acute ischemic stroke in the right or left MCA territory, admitted to University Hospital, London Health Sciences Centre (LHSC) or evaluated at LHSC's Urgent TIA and Stroke Prevention Clinic. Acute ischemic stroke is defined as acute onset focal symptoms matching an acute brain infarct documented on a Head CT or on diffusion weighted imaging (DWI) MRI of the brain showing restricted diffusion.
* Willing to consent.

Exclusion Criteria

* History of known heart disease defined as known atrial fibrillation, prior myocardial infarction, coronary artery disease, heart failure, prior cardiovascular surgery or percutaneous intervention
* Stroke in the previous 3 months before the qualifying stroke.
* High-sensitivity Troponin-T (HS-TnT) \>100 ng/L on routine standard of care acute stroke bloodwork.
* Clinically or neurologically unstable patients as per the treating physician.
* Ongoing infection or recent infection within the previous 3 months.
* Surgery within 3 months before the stroke.
* Concurrent inflammatory conditions (connective tissue diseases, rheumatological disease, etc.) or use of anti-inflammatory medications.
* Contraindications to the use of gadolinium (e.g., pregnancy, stage IV renal insufficiency)
* Subjects will be excluded if they fail the St. Joseph's Health Care standard MRI screening questionnaire. Briefly, this questionnaire screens for: Heart Pacemakers / Wires, Aneurysm Clips, Shunt / Surgical Clips, Shrapnel / Bullets, Dentures or Metal braces, Intra-Uterine Device, Heart Valves, Ear Implants, Prostheses, Medication Patches (Nicoderm, Habitrol, Transderm-Nitro, etc.), Claustrophobia, History of a head or eye injury involving metal fragments. Patients with an eGFR \< 40 will be excluded, as impaired renal function places the patient at a higher risk for a rare reaction to Gd-DTPA, the MRI contrast agent.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Luciano Sposato, MD

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Center, Western University

Locations

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Heart & Brain Lab, Western University

London, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Diana Ayan, MSc

Role: CONTACT

+1 519.685.8500 ext. 35826

Jennifer Moussa

Role: CONTACT

+1 519.685.8500 ext. 33110

Facility Contacts

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Diana Ayan, MSc

Role: primary

+1(519) 685-8500 ext. 35286

Jennifer Moussa

Role: backup

+1(519) 685-8500 ext. 33110

Other Identifiers

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R-22-507

Identifier Type: -

Identifier Source: org_study_id

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