MR Evidence of Cardiac Inflammation Post-Stroke

NCT05714618 | Unknown

• 1 other identifier: R-21-323
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• The severity of left ventricular myocardial inflammation on cardiac MRI within 10 days post-stroke

  Proportion of left ventricular myocardium showing inflammatory changes on gadolinium-enhanced cardiac MRI

  Within 10 days of stroke onset

• The extent of left ventricular fibrosis measured on gadolinium-enhanced cardiac MRI within 10 days of stroke onset

  Proportion of left ventricular myocardium showing fibrosis on gadolinium-enhanced cardiac MRI

  Within 10 days of stroke onset

Secondary Outcomes (5)

• 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 inflammation 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 fibrosis measured on gadolinium-enhanced cardiac MRI at 10 and 60±15 days post-stroke

  At 60±15 days compared to first 10 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: Gadolinium-enhanced cardiac MRI; Diagnostic Test: B Natriuretic Peptide; Diagnostic Test: Systemic inflammatory markers

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

Interventions

Gadolinium-enhanced cardiac MRI DIAGNOSTIC_TEST

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

Cases (Ischemic stroke): Left and right middle cerebral artery ischemic stroke; Controls (TIA): Patients with acute focal neurological symptoms without brain infarct on MRI.

B Natriuretic Peptide DIAGNOSTIC_TEST

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

Cases (Ischemic stroke): Left and right middle cerebral artery ischemic stroke; Controls (TIA): Patients with acute focal neurological symptoms without brain infarct on MRI.

Systemic inflammatory markers DIAGNOSTIC_TEST

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

Cases (Ischemic stroke): Left and right middle cerebral artery ischemic stroke; Controls (TIA): Patients with acute focal neurological symptoms without brain infarct on MRI.

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 investigators will include 44 patients with right (n=22) and left (n=22) MCA ischemic stroke. The investigators aim to include at least 50% of female patients. The investigators will include 24 participants in a control group. Participants in the control group will be patients presenting with acute stroke symptoms but no evidence of acute brain infarction on DWI-MRI imaging. Participants will be divided by sex: the investigators aim to enroll 12 female and 12 male participants. The investigators will aim to enroll participants within the same age range as the stroke participants.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• McMaster University: collaborator
• Western University, Canada: collaborator

Study Sites (1)

Heart & Brain Lab, Western University

London, Ontario, N6A 5A5, Canada

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Inflammation

Condition Hierarchy (Ancestors)

Stroke; 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: January 31, 2022
• First Posted: February 6, 2023
• Study Start: October 1, 2021
• Primary Completion: June 16, 2025
• Study Completion: December 31, 2025
• Last Updated: September 20, 2024

Record last verified: 2023-10

Locations

CA (1)