Recruiting

PET/MR

Sponsor:

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

Code:

NCT05791617

Conditions

Stroke

Inflammation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

cardiac PET/MRI

Inflammatory markers

Diagnostic Test: NT-proBNP

Study Details

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

Study ID

NCT05791617

Start date

Jul 1, 2023

Status verified date

Mar, 2024

Completion date

Sep 2, 2025

Anticipated

Primary completion date

Sep 2, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

12 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

Interventions

cardiac PET/MRI

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

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

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

Primary outcome measure

  • Cardiac Inflammation Levels at 30±5 Days Post-Stroke measured by PET/MR Scanning [ Time Frame: At 30 days±5 post stroke ]
  • Cardiac Inflammation Levels at 90±5 Days Post-Stroke measured by PET/MR Scanning [ Time Frame: At 90±5 days compared to first 30 days±5 post-stroke ]

Central Contacts and Locations

Central contacts

Diana Ayan, MSc

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

Jennifer Moussa

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

Locations

Heart & Brain Lab, Western University

Recruiting

London, Ontario, Canada, N6A 5A5

Contacts

Diana Ayan, MSc

+1(519) 685-8500diana.ayan@lhsc.on.ca

Jennifer Moussa

+1(519) 685-8500jennifer.moussa@lhsc.on.ca

Principal Investigator:

Luciano Sposato, MD

More Information

Sponsor

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

Last update posted

Mar 13, 2024

Last verified

Mar, 2024

Keywords

  • stroke
  • PET/MRI
  • Inflammation
  • Heart

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2024-03-13.