PET/MR in Post Stroke Cardiac Inflammation Study

NCT05791617 | Recruiting

• 1 other identifier: R-22-507
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke; Inflammation

Keywords

stroke; PET/MRI; Inflammation; Heart

Outcome Measures

Primary Outcomes (2)

• Cardiac Inflammation Levels at 30±5 Days Post-Stroke measured by PET/MR Scanning

  Cardiac inflammation as measure on PET/MR scanning.

  At 30 days±5 post stroke

• Cardiac Inflammation Levels at 90±5 Days Post-Stroke measured by PET/MR Scanning

  Cardiac inflammation as measure on PET/MR scanning.

  At 90±5 days compared to first 30 days±5 post-stroke

Secondary Outcomes (2)

• Change in B-Type Natriuretic Peptide (NT-proBNP) and HS-TnT levels between 30±5 days and 90±5 days post-stroke.

  At 90±5 days compared to first 30±5 days post stroke

• Change in systemic inflammatory markers between 30±5 and 90±5 days post-stroke

  At 90±5 days compared to first 30±5 days

Study Arms (2)

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.

Diagnostic Test: cardiac PET/MRI; Diagnostic Test: Inflammatory markers; Diagnostic Test: Diagnostic Test: NT-proBNP

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.

Diagnostic Test: cardiac PET/MRI; Diagnostic Test: Inflammatory markers; Diagnostic Test: Diagnostic Test: NT-proBNP

Interventions

cardiac PET/MRI DIAGNOSTIC_TEST

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

Cases (Ischemic stroke); Controls (TIA)

Inflammatory markers 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

Also known as: Olink® Target-96 inflammatory biomarker panel

Cases (Ischemic stroke); Controls (TIA)

Diagnostic Test: NT-proBNP 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

Also known as: N-terminal prohormone of brain natriuretic peptide

Cases (Ischemic stroke); Controls (TIA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will comprise 4 patients with acute ischemic stroke in the right MCA territory involving the insular cortex, 4 patients in the left MCA territory involving the insular cortex, and 4 age- and sex-matched individuals presenting with acute stroke symptoms but no evidence of stroke on brain MRI.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Heart & Brain Lab, Western University

London, Ontario, N6A 5A5, Canada

RECRUITING

MeSH Terms

Conditions

Stroke; Inflammation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Luciano Sposato, MD

  London Health Sciences Center, Western University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Diana Ayan, MSc

CONTACT

+1 519.685.8500; diana.ayan@lhsc.on.ca

Jennifer Moussa

CONTACT

+1 519.685.8500; jennifer.moussa@lhsc.on.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: March 30, 2023
• Study Start: July 1, 2023
• Primary Completion: September 2, 2024
• Study Completion: September 2, 2025
• Last Updated: March 13, 2024

Record last verified: 2024-03

Locations

CA (1)