ClinicalTrials.gg
RecruitingNCT05714618MIRACLEUpdated Sep 18, 2026

MR Evidence of Cardiac Inflammation Post-Stroke

An observational study in Stroke, Ischemic, Inflammation and Myocardial Injury, sponsored by Luciano A. Sposato. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-18.

Sponsored by Luciano A. Sposato · Observational

From the registry’s dates

  • Started Oct 2021; still recruiting 5 years 1 month later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
44
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Stroke, Ischemic
  • Inflammation
  • Myocardial Injury
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In context

Ischemic Stroke

2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.

This study's planned enrollment of 44 is below the median of 300 across 771 observational studies indexed under Ischemic Stroke.

Browse Ischemic Stroke studies →

Lead sponsor

Luciano A. Sposato is the lead sponsor of 7 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 \<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, \<30, and any other 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
44 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testGadolinium-enhanced cardiac MRI

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

  • Diagnostic testB Natriuretic Peptide

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

  • Diagnostic testSystemic inflammatory markers

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

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What researchers measure

Primary outcomes

  1. 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

    Time frame: Within 10 days of stroke onset

  2. 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

    Time frame: Within 10 days of stroke onset

Secondary outcomes

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

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

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

  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.

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

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

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

    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

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

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

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

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

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

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

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

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2021 (actual). Primary completion is estimated for Jun 2027, 68 months after the start.

Of 394 non-industry observational studies under Ischemic Stroke, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 140. This study's planned 68 months is above that.

Counting every sponsor, half of 436 studies reached it within 53 months; a quarter within 24 and three quarters within 127.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 31, 2022
First posted
Feb 6, 2023
StartActual
Oct 1, 2021
Primary completionEst.
Jun 16, 2027
CompletionEst.
Dec 31, 2027
Last update
Sep 18, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05714618
Lead sponsor
Luciano A. Sposato
Responsible party
Luciano A. Sposato (Neurologist, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's) — Sponsor-investigator
First posted
Feb 6, 2023
Start date
Oct 1, 2021
Primary completion
Jun 16, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Sep 18, 2026

Study contacts

Diana Ayan, MSc
Contact
diana.ayan@lhsc.on.ca
+1 519.685.8500 ext. 35826
Jennifer Moussa
Contact
jennifer.moussa@lhsc.on.ca
+1 519.685.8500 ext. 33110
Luciano Sposato, MD
principal investigator · London Health Sciences Center, Western University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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