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Clinical Trials/NCT05714618
NCT05714618
Recruiting
Not Applicable

Magnetic Resonance Imaging Evidence of Cardiac Inflammation Post-Stroke

Lawson Health Research Institute1 site in 1 country44 target enrollmentOctober 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke, Ischemic
Sponsor
Lawson Health Research Institute
Enrollment
44
Locations
1
Primary Endpoint
The extent of left ventricular fibrosis measured on gadolinium-enhanced cardiac MRI within 10 days of stroke onset
Status
Recruiting
Last Updated
2 years ago

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2021
End Date
December 31, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

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)

Study Sites (1)

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