MR Evidence of Cardiac Inflammation Post-Stroke

Inflammation Clinical Trial

— MIRACLE  

Official title:

Magnetic Resonance Imaging Evidence of Cardiac Inflammation Post-Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05714618
• Other study ID #: R-21-323
• Status: Recruiting
• Start date: October 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2023
• 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

The present study is an investigator initiated, single-centre, prospective, proof-of-concept cohort study aiming to enroll 44 patients with acute middle cerebral artery (MCA) ischemic stroke, involving the right (n=22) and left (n=22) MCA territories and 24 control patients with acute focal neurological symptoms but no evidence of acute brain infarct on DWI-MRI.

Description:

The present study is an investigator-initiated, single-center, prospective cohort study. The study aims to enroll 44 patients with acute/subacute middle cerebral artery (MCA) ischemic stroke. The investigators will compare inflammatory markers among 44 patients with MCA ischemic stroke within 10 days post-stroke vs. 60±15 days post-stroke. Other measures to be determined at both time points include B-Type Natriuretic Peptide and systemic inflammatory markers.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: December 31, 2024
• Est. primary completion date: June 16, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Acute ischemic stroke in the right or left MCA territory. Acute ischemic stroke is defined as acute onset focal symptoms matching an acute brain infarct documented on Head computed tomography or diffusion-weighted imaging (DWI) MRI of the brain showing restricted diffusion.

Exclusion Criteria:

• History of known atrial fibrillation, prior myocardial infarction, coronary artery disease, heart failure, prior cardiovascular surgery or percutaneous intervention.

• Previous stroke (occurred within 3 months before the index event)

• Impaired renal function defined as a creatinine clearance <97 mL/min in men or <88 mL/min in women, according to the Cockcroft formula.

• hs-TnT >100 on routine acute stroke baseline bloodwork upon admission.

• 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 and active inflammatory conditions (connective tissue diseases, rheumatological disease, etc.) or use of anti-inflammatory medications

• Pregnancy, Stage IV renal insufficiency, eGFR <30, and any other contraindications to the use of gadolinium.

• Stroke with symptomatic hemorrhagic transformation

• Subjects will be excluded if they fail the LHSC standard MRI screening questionnaire (cardiac pacemakers/wires, aneurysm clips, shunt/surgical clips, shrapnel/bullets, dentures or metal braces, intra-uterine devices, heart valves, ear implants, prostheses, medication patches such as Nicoderm, Habitrol, or Transderm-Nitro, claustrophobia, history of a head or eye injury involving metal fragments.

Related Conditions & MeSH terms

• Inflammation
• Ischemic Stroke
• Myocardial Injury
• Stroke
• Stroke, Ischemic

Intervention

Diagnostic Test:
• Gadolinium-enhanced cardiac MRI
Cardiac magnetic resonance imaging (MRI) with a protocol designed to measure myocardial inflammation and fibrosis.
• B Natriuretic Peptide
Measurement of B Natriuretic Peptide on patients' blood samples at 10 and 60+/-15 days.
• Systemic inflammatory markers
Measurement of a panel of 92 systemic inflammatory markers on patients' blood samples at 10 and 60+/-15 days.

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Lawson Health Research Institute	McMaster University, Western University, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The severity of left ventricular myocardial inflammation on cardiac MRI within 10 days post-stroke	Proportion of left ventricular myocardium showing inflammatory changes on gadolinium-enhanced cardiac MRI	Within 10 days of stroke onset
Primary	The extent of left ventricular fibrosis measured on gadolinium-enhanced cardiac MRI within 10 days of stroke onset	Proportion of left ventricular myocardium showing fibrosis on gadolinium-enhanced cardiac MRI	Within 10 days of stroke onset
Secondary	Changes in left ventricular inflammation measured on gadolinium-enhanced cardiac MRI at 10 and 60±15 days post-stroke	Quantification of left ventricular inflammation measured on gadolinium-enhanced cardiac MRI	At 60±15 days compared to first 10 days
Secondary	Change in B-Type Natriuretic Peptide (NT-proBNP) levels in the second measurement performed at 60±15 days post-stroke relative to the plasma sample drawn within 10 days.	Change in levels of NT-proBNP between 10 and 60±15 days post-stroke	At 60±15 days compared to first 10 days
Secondary	Change in systemic inflammatory markers between 10 and 60±15 days post-stroke	High-performance protein biomarker panel for following 92 inflammatory biomarkers 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 60±15 days compared to first 10 days
Secondary	Changes in left atrial inflammation measured on gadolinium-enhanced cardiac MRI at 10 and 60±15 days post-stroke	Quantification of left atrial inflammation measured on gadolinium-enhanced cardiac MRI	At 60±15 days compared to first 10 days
Secondary	Changes in left atrial fibrosis measured on gadolinium-enhanced cardiac MRI at 10 and 60±15 days post-stroke	Quantification of left atrial fibrosis measured on gadolinium-enhanced cardiac MRI	At 60±15 days compared to first 10 days