PET/MR in Post Stroke Cardiac Inflammation Study (PEPSI)

March 12, 2024 updated by: Lawson Health Research Institute
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • Recruiting
        • Heart & Brain Lab, Western University
        • Contact:
        • Principal Investigator:
          • Luciano Sposato, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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
Other Names:
  • Olink® Target-96 inflammatory biomarker panel
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
Other Names:
  • N-terminal prohormone of brain natriuretic peptide
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.
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
Other Names:
  • Olink® Target-96 inflammatory biomarker panel
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
Other Names:
  • N-terminal prohormone of brain natriuretic peptide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At 30 days±5 post stroke
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.
At 90±5 days compared to first 30 days±5 post-stroke

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Investigators

  • Principal Investigator: Luciano Sposato, MD, London Health Sciences Center, Western University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2023

Primary Completion (Estimated)

September 2, 2024

Study Completion (Estimated)

September 2, 2025

Study Registration Dates

First Submitted

February 8, 2023

First Submitted That Met QC Criteria

March 17, 2023

First Posted (Actual)

March 30, 2023

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-22-507

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on cardiac PET/MRI

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe