Recruiting

Observational Study

Sponsor:

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

Code:

NCT05714618

Conditions

Stroke, Ischemic

Inflammation

Myocardial Injury

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Gadolinium-enhanced cardiac MRI

B Natriuretic Peptide

Systemic inflammatory markers

Study Details

Brief summary:

The present study is an investigator initiated, single-centre, prospective, proof-of-concept cohort study aiming to enroll 44 patients with acute middle cerebral artery (MCA) ischemic stroke, involving the right (n=22) and left (n=22) MCA territories and 24 control patients with acute focal neurological symptoms but no evidence of acute brain infarct on DWI-MRI.

Conditions

Stroke, Ischemic

Inflammation

Myocardial Injury

Study ID

NCT05714618

Start date

Oct 1, 2021

Status verified date

Oct, 2023

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Jun 16, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

• Acute ischemic stroke in the right or left MCA territory. Acute ischemic stroke is defined as acute onset focal symptoms matching an acute brain infarct documented on Head computed tomography or diffusion-weighted imaging (DWI) MRI of the brain showing restricted diffusion.

Exclusion Criteria:

  • History of known atrial fibrillation, prior myocardial infarction, coronary artery disease, heart failure, prior cardiovascular surgery or percutaneous intervention.
  • Previous stroke (occurred within 3 months before the index event)
  • Impaired renal function defined as a creatinine clearance <97 mL/min in men or <88 mL/min in women, according to the Cockcroft formula.
  • hs-TnT >100 on routine acute stroke baseline bloodwork upon admission.
  • 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 and active inflammatory conditions (connective tissue diseases, rheumatological disease, etc.) or use of anti-inflammatory medications
  • Pregnancy, Stage IV renal insufficiency, eGFR <30, and any other contraindications to the use of gadolinium.
  • Stroke with symptomatic hemorrhagic transformation
  • Subjects will be excluded if they fail the LHSC standard MRI screening questionnaire (cardiac pacemakers/wires, aneurysm clips, shunt/surgical clips, shrapnel/bullets, dentures or metal braces, intra-uterine devices, heart valves, ear implants, prostheses, medication patches such as Nicoderm, Habitrol, or Transderm-Nitro, claustrophobia, history of a head or eye injury involving metal fragments.

Study Design

Enrollment

44 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

Gadolinium-enhanced cardiac MRI

Cardiac magnetic resonance imaging (MRI) with a protocol designed to measure myocardial inflammation and fibrosis.

B Natriuretic Peptide

Measurement of B Natriuretic Peptide on patients' blood samples at 10 and 60+/-15 days.

Systemic inflammatory markers

Measurement of a panel of 92 systemic inflammatory markers on patients' blood samples at 10 and 60+/-15 days.

Primary outcome measure

  • The severity of left ventricular myocardial inflammation on cardiac MRI within 10 days post-stroke [ Time Frame: Within 10 days of stroke onset ]
  • The extent of left ventricular fibrosis measured on gadolinium-enhanced cardiac MRI within 10 days of stroke onset [ Time Frame: Within 10 days of stroke onset ]

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

More Information

Sponsor

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

Last update posted

Sep 20, 2024

Last verified

Oct, 2023

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 2024-09-20.