Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05714618

MR Evidence of Cardiac Inflammation Post-Stroke

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gadolinium-enhanced cardiac MRI

Diagnostic Test

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

B Natriuretic Peptide

Diagnostic Test

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

Systemic inflammatory markers

Diagnostic Test

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

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Changes in left ventricular inflammation measured on gadolinium-enhanced cardiac MRI at 10 and 60±15 days post-stroke

    Time frame: At 60±15 days compared to first 10 days

    Quantification of left ventricular inflammation measured on gadolinium-enhanced cardiac MRI

  2. 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.

    Time frame: At 60±15 days compared to first 10 days

    Change in levels of NT-proBNP between 10 and 60±15 days post-stroke

  3. Change in systemic inflammatory markers between 10 and 60±15 days post-stroke

    Time frame: At 60±15 days compared to first 10 days

    High-performance protein biomarker panel for following 92 inflammatory biomarkers in pg/mL

    ADA; ARTN; AXIN1; NGF; CCL13; CCL19; CCL2; CCL20; CCL23; CCL25; CCL28; CCL3; CCL4; CCL7; CCL8; CXCL10; CXCL11; CXCL5; CXCL6; CXCL9; CDCP1; CASP8; CST5; DNER; CCL11; EIF4EBP1; FGF19; FGF21; FGF23; FGF5; FLT3LG; CX3CL1; GDNF; CXCL1; HGF; IFNG; IL1A; IL10; IL10RA; IL10RB; IL12B; IL13; IL15RA; IL17A; IL17C; IL18; IL18R1; IL2; IL2RB; IL20; IL20RA; IL22RA1; IL24; IL33; IL4; IL5; IL6; IL7; CXCL8; MMP1; KITLG; LIF; LIFR; LTA; CSF1; SIRT2; CD244;NTF3;NRTN;OSM;CD274;S100A12;TGFA;STAMBP;SLAMF1;MMP10;SULT1A1;CD6;CD5;CD8A;TSLP;TGFB1;TNF;TNFSF10;TNFSF11;TNFSF12;TNFSF14;TNFRSF11B;CD40;TNFRSF9;PLAU;VEGFA

  4. Changes in left atrial inflammation measured on gadolinium-enhanced cardiac MRI at 10 and 60±15 days post-stroke

    Time frame: At 60±15 days compared to first 10 days

    Quantification of left atrial inflammation measured on gadolinium-enhanced cardiac MRI

  5. Changes in left atrial fibrosis measured on gadolinium-enhanced cardiac MRI at 10 and 60±15 days post-stroke

    Time frame: At 60±15 days compared to first 10 days

    Quantification of left atrial fibrosis measured on gadolinium-enhanced cardiac MRI

Study contacts

Contact information is provided by the study sponsor or research team.

Diana Ayan, MSc

CONTACT

[email protected]

+1 519.685.8500 ext. 35826

Jennifer Moussa

CONTACT

[email protected]

+1 519.685.8500 ext. 33110

Sponsors and collaborators

Lead sponsor

Luciano A. Sposato

Other

Collaborators

  • McMaster University
  • Western University, Canada

Registry information

Official study title

Magnetic Resonance Imaging Evidence of Cardiac Inflammation Post-Stroke

Acronym: MIRACLE

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Feb 6, 2023
Registry last updated
Sep 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.