Current partner codePEPTIDESDE
NCT05791617·Not applicable·OBSERVATIONAL

PET/MR in Post Stroke Cardiac Inflammation Study

Status

Unknown

Phase

Not applicable

Enrollment

12

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DIAGNOSTIC_TEST

cardiac PET/MRI

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

DIAGNOSTIC_TEST

Inflammatory 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_TEST

Diagnostic 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

Timeline

From registration to results.

  1. First posted

    Mar 30, 2023

  2. Study start

    Jul 1, 2023

  3. Primary completion

    Sep 2, 2024

  4. Study completion

    Sep 2, 2025

  5. Results posted

    Not reported

  6. Registry updated

    Mar 13, 2024

Outcomes

What the study measures.

Primary outcomes

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.

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 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-stroke

Time frame · At 90±5 days compared to first 30±5 days

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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
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.

Study locations

1 registered sites.

Canada. Showing up to 24 locations stored in the fast local snapshot.

Heart & Brain Lab, Western University

London, Ontario, Canada

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

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