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PET/MR in Post Stroke Cardiac Inflammation Study

PET/MR in Post Stroke Cardiac Inflammation Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05791617
Acronym
PEPSI
Enrollment
12
Registered
2023-03-30
Start date
2023-07-01
Completion date
2025-09-02
Last updated
2024-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke, Inflammation

Keywords

stroke, PET/MRI, Inflammation, Heart

Brief 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. 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.

Interventions

DIAGNOSTIC_TESTcardiac PET/MRI

Patients will undergo cardiac PET/MRI scanning at 30±5 days and at 90±5 days post-stroke.

DIAGNOSTIC_TESTInflammatory markers

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_TESTDiagnostic Test: NT-proBNP

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

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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. * 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.

Design outcomes

Primary

MeasureTime frameDescription
Cardiac Inflammation Levels at 30±5 Days Post-Stroke measured by PET/MR ScanningAt 30 days±5 post strokeCardiac inflammation as measure on PET/MR scanning.
Cardiac Inflammation Levels at 90±5 Days Post-Stroke measured by PET/MR ScanningAt 90±5 days compared to first 30 days±5 post-strokeCardiac inflammation as measure on PET/MR scanning.

Secondary

MeasureTime frameDescription
Change in B-Type Natriuretic Peptide (NT-proBNP) and HS-TnT levels between 30±5 days and 90±5 days post-stroke.At 90±5 days compared to first 30±5 days post strokeChange in levels of NT-proBNP and HS-TnT between 30±5 and 90±15 days post-stroke.
Change in systemic inflammatory markers between 30±5 and 90±5 days post-strokeAt 90±5 days compared to first 30±5 daysSystemic 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

Countries

Canada

Contacts

Primary ContactDiana Ayan, MSc
diana.ayan@lhsc.on.ca+1 519.685.8500
Backup ContactJennifer Moussa
jennifer.moussa@lhsc.on.ca+1 519.685.8500

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026