MR Evidence of Cardiac Inflammation Post-Stroke

NCT ID: NCT05714618

Last Updated: 2024-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

44 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-01

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Stroke, Ischemic Inflammation Myocardial Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Gadolinium-enhanced cardiac MRI

Intervention Type DIAGNOSTIC_TEST

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

B Natriuretic Peptide

Intervention Type DIAGNOSTIC_TEST

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

Systemic inflammatory markers

Intervention Type DIAGNOSTIC_TEST

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

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.

Gadolinium-enhanced cardiac MRI

Intervention Type DIAGNOSTIC_TEST

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

B Natriuretic Peptide

Intervention Type DIAGNOSTIC_TEST

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

Systemic inflammatory markers

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Gadolinium-enhanced cardiac MRI

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

Intervention Type DIAGNOSTIC_TEST

B Natriuretic Peptide

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

Intervention Type DIAGNOSTIC_TEST

Systemic inflammatory markers

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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McMaster University

OTHER

Sponsor Role collaborator

Western University, Canada

OTHER

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Luciano Sposato, MD

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Center, Western University

Locations

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Heart & Brain Lab, Western University

London, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Diana Ayan, MSc

Role: CONTACT

+1 519.685.8500 ext. 35826

Jennifer Moussa

Role: CONTACT

+1 519.685.8500 ext. 33110

Facility Contacts

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Diana Ayan, MSc

Role: primary

+1(519) 685-8500 ext. 35826

Jennifer Moussa

Role: backup

+1(519) 685-8500 ext. 33110

Luciano Sposato, MD, MBA

Role: backup

Other Identifiers

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R-21-323

Identifier Type: -

Identifier Source: org_study_id

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