MR Evidence of Cardiac Inflammation Post-Stroke (MIRACLE)

Lawson Health Research Institute

Status: Enrolling

Conditions: Inflammation; Stroke, Ischemic; Myocardial Injury

Treatments: Diagnostic Test: Gadolinium-enhanced cardiac MRI; Diagnostic Test: Systemic inflammatory markers; Diagnostic Test: B Natriuretic Peptide

Study type: Observational

Funder types: Other

Identifiers

NCT05714618

R-21-323

Details and patient eligibility

About

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.

Full description

The present study is an investigator-initiated, single-center, prospective cohort study. The study aims to enroll 44 patients with acute/subacute middle cerebral artery (MCA) ischemic stroke. The investigators will compare inflammatory markers among 44 patients with MCA ischemic stroke within 10 days post-stroke vs. 60±15 days post-stroke. Other measures to be determined at both time points include B-Type Natriuretic Peptide and systemic inflammatory markers.

Enrollment: 44 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

44 participants in 2 patient groups

Cases (Ischemic stroke): Left and right middle cerebral artery ischemic stroke

Description:

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.

Treatment:

Diagnostic Test: B Natriuretic Peptide

Diagnostic Test: Systemic inflammatory markers

Diagnostic Test: Gadolinium-enhanced cardiac MRI

Controls (TIA): Patients with acute focal neurological symptoms without brain infarct on MRI.

Description:

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

Treatment:

Diagnostic Test: B Natriuretic Peptide

Diagnostic Test: Systemic inflammatory markers

Diagnostic Test: Gadolinium-enhanced cardiac MRI