Stroke, IschemicMIRACLENCT05714618
MR Evidence of Cardiac Inflammation Post-Stroke
An observational study of Stroke, Ischemic and Inflammation, run by Luciano A. Sposato at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemic, Inflammation, Myocardial Injury
- What is being tested?
- Gadolinium-enhanced cardiac MRI, B Natriuretic Peptide and Systemic inflammatory markers
- How many people
- 44 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2021to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Heart & Brain Lab, Western University
London, Ontario, N6A 5A5
Diana Ayan, MSc, +1(519) 685-8500 ext. 35826, diana.ayan@lhsc.on.ca
Jennifer Moussa, +1(519) 685-8500 ext. 33110, jennifer.moussa@lhsc.on.ca
About this study
Official title: Magnetic Resonance Imaging 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.
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.
- Conditions
- Stroke, Ischemic, Inflammation, Myocardial Injury
- Being tested
- Gadolinium-enhanced cardiac MRI, B Natriuretic Peptide, Systemic inflammatory markers
- Medical subject headings
- Ischemic Stroke, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gadolinium-enhanced cardiac MRIDiagnostic test
Cardiac magnetic resonance imaging (MRI) with a protocol designed to measure myocardial inflammation and fibrosis.
B Natriuretic PeptideDiagnostic test
Measurement of B Natriuretic Peptide on patients' blood samples at 10 and 60+/-15 days.
Systemic inflammatory markersDiagnostic test
Measurement of a panel of 92 systemic inflammatory markers on patients' blood samples at 10 and 60+/-15 days.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Gadolinium-enhanced cardiac MRI; Diagnostic Test: B Natriuretic Peptide; Diagnostic Test: Systemic inflammatory markers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Quantification of left ventricular inflammation measured on gadolinium-enhanced cardiac MRI
Measured: 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.
Change in levels of NT-proBNP between 10 and 60±15 days post-stroke
Measured: At 60±15 days compared to first 10 days
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
Measured: 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
Quantification of left atrial inflammation measured on gadolinium-enhanced cardiac MRI
Measured: 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
Quantification of left atrial fibrosis measured on gadolinium-enhanced cardiac MRI
Measured: At 60±15 days compared to first 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start1 Oct 2021
- Primary completion16 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luciano A. Sposato
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University, Western University, Canada
- Responsible party
- Sponsor-investigator, Luciano A. Sposato, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Luciano Sposato, MD, Principal investigator, London Health Sciences Center, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05714618
- Sponsor's protocol ID
- R-21-323
- Acronym
- MIRACLE
- Status last verified
- Sep 2026
- First submitted
- 31 Jan 2022
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Imaging Evidence of Cardiac Inflammation Post-Stroke
- ClinicalTrials.gov ID
- NCT05714618
- Acronym / sponsor ID
- MIRACLE / R-21-323
- Conditions
- Stroke, Ischemic, Inflammation, Myocardial Injury
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Luciano A. SposatoUniversity, hospital or other
- Collaborators
- McMaster University, Western University, Canada
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 16 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases (Ischemic stroke): Left and right middle cerebral artery ischemic stroke | – | Diagnostic Test: Gadolinium-enhanced cardiac MRI, Diagnostic Test: B Natriuretic Peptide, Diagnostic Test: Systemic inflammatory markersPatients 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. |
| Controls (TIA): Patients with acute focal neurological symptoms without brain infarct on MRI. | – | Diagnostic Test: Gadolinium-enhanced cardiac MRI, Diagnostic Test: B Natriuretic Peptide, Diagnostic Test: Systemic inflammatory markersPatients presenting with acute onset focal neurological deficits presumed to be of vascular origin, WITHOUT DWI-MRI evidence of an acute brain infarct. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gadolinium-enhanced cardiac MRICardiac magnetic resonance imaging (MRI) with a protocol designed to measure myocardial inflammation and fibrosis. | Diagnostic test | 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 PeptideMeasurement of B Natriuretic Peptide on patients' blood samples at 10 and 60+/-15 days. | Diagnostic test | 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 markersMeasurement of a panel of 92 systemic inflammatory markers on patients' blood samples at 10 and 60+/-15 days. | Diagnostic test | Cases (Ischemic stroke): Left and right middle cerebral artery ischemic stroke, Controls (TIA): Patients with acute focal neurological symptoms without brain infarct on MRI. |
Primary outcome
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
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
5 secondary outcomes
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
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 systemic inflammatory markers between 10 and 60±15 days post-stroke
Time frame: 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
Time frame: 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
Time frame: At 60±15 days compared to first 10 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Stroke, Ischemic
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Recruiting
Biomarkers of Paired VNS
Stroke, Ischemic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Luciano Sposato, MD principal investigator
London Health Sciences Center, Western University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Ischemic and Inflammation, run by Luciano A. Sposato at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Diana Ayan, MSc (+1 519.685.8500 ext. 35826, diana.ayan@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The severity of left ventricular myocardial inflammation on cardiac MRI within 10 days post-stroke (time frame: Within 10 days of stroke onset). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.