StrokePEPSINCT05791617
PET/MR in Post Stroke Cardiac Inflammation Study
An observational study of Stroke and Inflammation, run by Luciano A. Sposato at 1 site in Canada.
Trial summary
Patients with stroke have a 25x higher risk of cardiovascular complications within the first 30 days of the event compared to individuals without stroke. The mechanisms behind these complications are not well understood. Evidence suggests that inflammation plays a central role. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Inflammation
- What is being tested?
- cardiac PET/MRI, Inflammatory markers and Diagnostic Test: NT-proBNP
- How many people
- 1 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2023to 13 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 study population will comprise 4 patients with acute ischemic stroke in the right MCA territory involving the insular cortex, 4 patients in the left MCA territory involving the insular cortex, and 4 age- and sex-matched individuals presenting with acute stroke symptoms but no evidence of stroke on brain MRI.
Who may be able to join
- Age ≥18 years willing to cons Age ≥18 years willing to consent
- Patients with acute ischemic stroke in the right or left MCA territory, admitted to University Hospital, London Health Sciences Centre (LHSC) or evaluated at LHSC's Urgent TIA and Stroke Prevention Clinic. Acute ischemic stroke is defined as acute onset focal symptoms matching an acute brain infarct documented on a Head CT or on diffusion weighted imaging (DWI) MRI of the brain showing restricted diffusion.
- Willing to consent.
Who cannot join
- History of known heart disease defined as known atrial fibrillation, prior myocardial infarction, coronary artery disease, heart failure, prior cardiovascular surgery or percutaneous intervention
- Stroke in the previous 3 months before the qualifying stroke.
- High-sensitivity Troponin-T (HS-TnT) >100 ng/L on routine standard of care acute stroke bloodwork.
- 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.
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- Concurrent inflammatory conditions (connective tissue diseases, rheumatological disease, etc.) or use of anti-inflammatory medications.
- Contraindications to the use of gadolinium (e.g., pregnancy, stage IV renal insufficiency)
- Subjects will be excluded if they fail the St. Joseph's Health Care standard MRI screening questionnaire. Briefly, this questionnaire screens for: Heart Pacemakers / Wires, Aneurysm Clips, Shunt / Surgical Clips, Shrapnel / Bullets, Dentures or Metal braces, Intra-Uterine Device, Heart Valves, Ear Implants, Prostheses, Medication Patches (Nicoderm, Habitrol, Transderm-Nitro, etc.), Claustrophobia, History of a head or eye injury involving metal fragments. Patients with an eGFR < 40 will be excluded, as impaired renal function places the patient at a higher risk for a rare reaction to Gd-DTPA, the MRI contrast agent.
Trial locations and contacts
1 site in 1 country.
About this study
Patients with stroke have a 25x higher risk of cardiovascular complications within the first 30 days of the event compared to individuals without stroke. The mechanisms behind these complications are not well understood. Evidence suggests that inflammation plays a central role. With the present proof-of-concept prospective cohort study, the investigators aim to demonstrate that patients develop cardiac inflammation after stroke by performing positron emission tomography (PET) magnetic resonance imaging (MRI) of the heart within 15 days after stroke. As a secondary aim, the investigators will evaluate whether post-stroke cardiac inflammation persists at 3 months after stroke. The control group will be comprised of age- and sex-matched individuals without stroke.
- Conditions
- Stroke, Inflammation
- Being tested
- cardiac PET/MRI, Inflammatory markers, Diagnostic Test: NT-proBNP
- Keywords
- stroke, PET/MRI, Inflammation, Heart
- Medical subject headings
- Stroke, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac PET/MRIDiagnostic test
Patients will undergo cardiac PET/MRI scanning at 30±5 days and at 90±5 days post-stroke.
Inflammatory markersDiagnostic test
Also called Olink® Target-96 inflammatory biomarker panel
Measurement of a panel of 92 systemic inflammatory markers on patients' blood samples at 30±5 days and at 90±5 days post-stroke
Diagnostic Test: NT-proBNPDiagnostic test
Also called N-terminal prohormone of brain natriuretic peptide
NT-proBNP is useful both in the diagnosis and prognosis of heart failure and is considered to be a gold standard biomarker in heart failure. Measurement of NT-proBNP on patients' blood samples at 30±5 days and at 90±5 days post-stroke
| 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: cardiac PET/MRI; Diagnostic Test: Inflammatory markers; Diagnostic Test: Diagnostic Test: NT-proBNP | |
| 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: cardiac PET/MRI; Diagnostic Test: Inflammatory markers; Diagnostic Test: Diagnostic Test: NT-proBNP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Inflammation Levels at 30±5 Days Post-Stroke measured by PET/MR Scanning
Cardiac inflammation as measure on PET/MR scanning.
Measured: At 30 days±5 post stroke
Cardiac Inflammation Levels at 90±5 Days Post-Stroke measured by PET/MR Scanning
Cardiac inflammation as measure on PET/MR scanning.
Measured: At 90±5 days compared to first 30 days±5 post-stroke
Secondary outcomes (2)
Change in B-Type Natriuretic Peptide (NT-proBNP) and HS-TnT levels between 30±5 days and 90±5 days post-stroke.
Change in levels of NT-proBNP and HS-TnT between 30±5 and 90±15 days post-stroke.
Measured: At 90±5 days compared to first 30±5 days post stroke
Change in systemic inflammatory markers between 30±5 and 90±5 days post-stroke
Systemic inflammatory markers will be measured using a high-performance biomarker panel for the following 92 proteins (all of which will be informed 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 90±5 days compared to first 30±5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start1 Jul 2023
- Primary completion13 Jul 2026
- Study completion13 Jul 2026
Why it stopped: Study terminated prematurely due to recruitment challenges.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luciano A. Sposato
- Sponsor type
- University, hospital or other
- 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
- NCT05791617
- Sponsor's protocol ID
- R-22-507
- Acronym
- PEPSI
- Status last verified
- Sep 2026
- First submitted
- 8 Feb 2023
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
- PET/MR in Post Stroke Cardiac Inflammation Study
- ClinicalTrials.gov ID
- NCT05791617
- Acronym / sponsor ID
- PEPSI / R-22-507
- Conditions
- Stroke, Inflammation
- Keywords
- stroke, PET/MRI, Inflammation, Heart
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study terminated prematurely due to recruitment challenges.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Luciano A. SposatoUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 13 Jul 2026 (actual)
- Study completion
- 13 Jul 2026 (actual)
- First posted
- 30 Mar 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.
Patients with stroke have a 25x higher risk of cardiovascular complications within the first 30 days of the event compared to individuals without stroke. The mechanisms behind these complications are not well understood. Evidence suggests that inflammation plays a central role. With the present proof-of-concept prospective cohort study, the investigators aim to demonstrate that patients develop cardiac inflammation after stroke by performing positron emission tomography (PET) magnetic resonance imaging (MRI) of the heart within 15 days after stroke. As a secondary aim, the investigators will evaluate whether post-stroke cardiac inflammation persists at 3 months after stroke. The control group will be comprised of age- and sex-matched individuals without stroke.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases (Ischemic stroke) | – | Diagnostic Test: cardiac PET/MRI, Diagnostic Test: Inflammatory markers, Diagnostic Test: Diagnostic Test: NT-proBNPLeft 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. |
| Controls (TIA) | – | Diagnostic Test: cardiac PET/MRI, Diagnostic Test: Inflammatory markers, Diagnostic Test: Diagnostic Test: NT-proBNPPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will comprise 4 patients with acute ischemic stroke in the right MCA territory involving the insular cortex, 4 patients in the left MCA territory involving the insular cortex, and 4 age- and sex-matched individuals presenting with acute stroke symptoms but no evidence of stroke on brain MRI.
Key inclusion criteria (3 listed)
- Age ≥18 years willing to cons Age ≥18 years willing to consent
- Patients with acute ischemic stroke in the right or left MCA territory, admitted to University Hospital, London Health Sciences Centre (LHSC) or evaluated at LHSC's Urgent TIA and Stroke Prevention Clinic. Acute ischemic stroke is defined as acute onset focal symptoms matching an acute brain infarct documented on a Head CT or on diffusion weighted imaging (DWI) MRI of the brain showing restricted diffusion.
- Willing to consent.
Key exclusion criteria (9 listed)
- History of known heart disease defined as known atrial fibrillation, prior myocardial infarction, coronary artery disease, heart failure, prior cardiovascular surgery or percutaneous intervention
- Stroke in the previous 3 months before the qualifying stroke.
- High-sensitivity Troponin-T (HS-TnT) >100 ng/L on routine standard of care acute stroke bloodwork.
- Clinically or neurologically unstable patients as per the treating physician.
- Ongoing infection or recent infection within the previous 3 months.
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 |
|---|---|---|
| cardiac PET/MRIPatients will undergo cardiac PET/MRI scanning at 30±5 days and at 90±5 days post-stroke. | Diagnostic test | Cases (Ischemic stroke), Controls (TIA) |
| Inflammatory markersAlso: Olink® Target-96 inflammatory biomarker panelMeasurement of a panel of 92 systemic inflammatory markers on patients' blood samples at 30±5 days and at 90±5 days post-stroke | Diagnostic test | Cases (Ischemic stroke), Controls (TIA) |
| Diagnostic Test: NT-proBNPAlso: N-terminal prohormone of brain natriuretic peptideNT-proBNP is useful both in the diagnosis and prognosis of heart failure and is considered to be a gold standard biomarker in heart failure. Measurement of NT-proBNP on patients' blood samples at 30±5 days and at 90±5 days post-stroke | Diagnostic test | Cases (Ischemic stroke), Controls (TIA) |
Primary outcome
Cardiac Inflammation Levels at 30±5 Days Post-Stroke measured by PET/MR Scanning
Time frame: At 30 days±5 post stroke
Cardiac inflammation as measure on PET/MR scanning.
Cardiac Inflammation Levels at 90±5 Days Post-Stroke measured by PET/MR Scanning
Time frame: At 90±5 days compared to first 30 days±5 post-stroke
Cardiac inflammation as measure on PET/MR scanning.
2 secondary outcomes
Change in B-Type Natriuretic Peptide (NT-proBNP) and HS-TnT levels between 30±5 days and 90±5 days post-stroke.
Time frame: At 90±5 days compared to first 30±5 days post stroke
Change in systemic inflammatory markers between 30±5 and 90±5 days post-stroke
Time frame: At 90±5 days compared to first 30±5 days
Results and safety
The study was stopped early (reason given: Study terminated prematurely due to recruitment challenges.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
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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. This study is not recruiting at the moment.
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 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 3 inclusion and 9 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: stopped early, 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?
The study was stopped early (reason given: Study terminated prematurely due to recruitment challenges.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac Inflammation Levels at 30±5 Days Post-Stroke measured by PET/MR Scanning (time frame: At 30 days±5 post stroke). 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.