Magnetic Resonance Imaging Evidence of Cardiac Inflammation Post-Stroke
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Luciano A. Sposato
- Enrollment
- 44
- Locations
- 2
- Primary Endpoint
- The extent of left ventricular fibrosis measured on gadolinium-enhanced cardiac MRI within 10 days of stroke onset
Study Overview
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.
Detailed 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: B Natriuretic Peptide (Diagnostic Test)
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.
Intervention: Systemic inflammatory markers (Diagnostic Test)
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.
Intervention: Gadolinium-enhanced cardiac MRI (Diagnostic Test)
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.
Intervention: Gadolinium-enhanced cardiac MRI (Diagnostic Test)
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.
Intervention: B Natriuretic Peptide (Diagnostic Test)
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.
Intervention: Systemic inflammatory markers (Diagnostic Test)
Outcomes
Primary Outcomes
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
Proportion of left ventricular myocardium showing fibrosis on gadolinium-enhanced cardiac MRI
The severity of left ventricular myocardial inflammation on cardiac MRI within 10 days post-stroke
Time Frame: Within 10 days of stroke onset
Proportion of left ventricular myocardium showing inflammatory changes on gadolinium-enhanced cardiac MRI
Secondary Outcomes
- Changes in left ventricular inflammation measured on gadolinium-enhanced cardiac MRI at 10 and 60±15 days post-stroke(At 60±15 days compared to first 10 days)
- Change in B-Type Natriuretic Peptide (NT-proBNP) levels in the second measurement performed at 60±15 days post-stroke relative to the plasma sample drawn within 10 days.(At 60±15 days compared to first 10 days)
- Change in systemic inflammatory markers between 10 and 60±15 days post-stroke(At 60±15 days compared to first 10 days)
- Changes in left atrial fibrosis measured on gadolinium-enhanced cardiac MRI at 10 and 60±15 days post-stroke(At 60±15 days compared to first 10 days)
- Changes in left atrial inflammation measured on gadolinium-enhanced cardiac MRI at 10 and 60±15 days post-stroke(At 60±15 days compared to first 10 days)
Investigators
Luciano A. Sposato
Neurologist
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's