PET/MR in Post Stroke Cardiac Inflammation Study

Stroke Clinical Trial

— PEPSI  

Official title:

PET/MR in Post Stroke Cardiac Inflammation Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05791617
• Other study ID #: R-22-507
• Status: Recruiting
• Start date: July 1, 2023
• Est. completion date: September 2, 2025

Study information

• Verified date: March 2024
• Source: Lawson Health Research Institute
• Contact: Diana Ayan, MSc
• Phone: +1 519.685.8500
• Email: diana.ayan[@]lhsc.on.ca
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: September 2, 2025
• Est. primary completion date: September 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Inflammation
• Stroke

Intervention

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

Locations

Country	Name	City	State
Canada	Heart & Brain Lab, Western University	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac Inflammation Levels at 30±5 Days Post-Stroke measured by PET/MR Scanning	Cardiac inflammation as measure on PET/MR scanning.	At 30 days±5 post stroke
Primary	Cardiac Inflammation Levels at 90±5 Days Post-Stroke measured by PET/MR Scanning	Cardiac inflammation as measure on PET/MR scanning.	At 90±5 days compared to first 30 days±5 post-stroke
Secondary	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.	At 90±5 days compared to first 30±5 days post stroke
Secondary	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	At 90±5 days compared to first 30±5 days