CASCS for Heart failure | Ischemic heart failure | Chronic myocardial infarction

Inclusion criteria

• {"criterion_text":"-\tAny subject meeting all of the following inclusion criteria and verified by the Investigator during the screening period, i.e. at visits 1 and 2, will be considered acceptable for trial inclusion."}
• {"criterion_text":"-\tSafety laboratory test results and pre-surgery serology are clinically acceptable to undergo surgery at Visits 1 and 2."}
• {"criterion_text":"-\tWomen of childbearing potential (WOCBP) including peri-menopausal women who have had a menstrual period within 1 year have to have a negative pregnancy test. Results must be available and negative for the subject to be entered in the trial."}
• {"criterion_text":"-\tWOCBP have to use an effective method of birth control 2 months prior to trial entry or to surgical intervention date and throughout the trial duration (defined as a method which results in a failure rate of less than 1% per year)."}
• {"criterion_text":"-\tSubject has understood and accepted to participate in the trial according to all trial procedures by signing the approved informed consent."}
• {"criterion_text":"-\tMale or female subjects aged >18"}
• {"criterion_text":"-\tPresence of a documented myocardial infarction due to coronary artery atherosclerotic disease as evidenced by conventional ECG criteria"}
• {"criterion_text":"-\tAn area of regional dysfunction, i.e. hypokinetic, akinetic or dyskinetic as assessed by echocardiography, ventriculography or MRI-scan."}
• {"criterion_text":"-\tThe evidence of scar tissue on MRI-scan as shown by (gadolinium) delayed enhancement."}
• {"criterion_text":"-\tLeft ventricular ejection fraction of ≥ 25% and ≤ 45% as determined by clinically indicated assessment of cardiac function (echocardiogram, X-ray, ventriculography, CT and/or MRI)."}
• {"criterion_text":"-\tNeed for revascularization including the infarcted area by CABG. If no further revascularization is clinically indicated at the time the patient is assessed for participation in the clinical trial this will be determined by a cardiologist who is not an investigator. No further revascularization may be indicated by no arteries with significant stenosis, adequate result of prior PCI, location and extent of any stenosis not suitable for angioplasty."}
• {"criterion_text":"-\tAbility to provide informed consent and follow-up with protocol procedures. Subject is, in the Investigator’s opinion, psychosocially, mentally and physically able to fully comply with this protocol, including the postoperative regimen and follow-up visits."}

Exclusion criteria

• {"criterion_text":"-\tNon-cardiovascular disease with life expectancy of less than 1 year"}
• {"criterion_text":"-\tNYHA class IV congestive heart failure."}
• {"criterion_text":"-\tEvidence of tumour on screening chest/abdominal/pelvic examination."}
• {"criterion_text":"-\tSubject is on a transplant list or having received a solid organ transplant at any point in the past."}
• {"criterion_text":"-\tPregnant or breast-feeding woman."}
• {"criterion_text":"-\tInvolved in or planning to engage in litigation related health problems."}
• {"criterion_text":"-\tSubject is a prisoner (incarcerated)."}
• {"criterion_text":"-\tSubject previously received a cellular therapy (at any point in time)."}
• {"criterion_text":"-\tSubject was exposed to therapy for a malignancy or pre-malignant entity, and not confirmed disease-free for 5 years or more."}
• {"criterion_text":"-\tAny clinically relevant chronic disease associated with renal or hepatic insufficiency or any chronic disease of such severity that surgery could be detrimental to the survival of the subject."}
• {"criterion_text":"-\tAny other illness which might reduce life expectancy to less than 2 years from screening."}
• {"criterion_text":"-\tContra indications to MRI, including prior (MRI non-compatible) ICD placement, estimated glomerular filtration rate less than 50 ml per minute, known reaction to gadolinium, claustrophobia, MRI non-compatible pacemaker and cochlear implant. History of possible presence of ferromagnetic material including programmable shunt, penile prosthesis, intrauterine device, bullets, tattoos, artificial limb, blood vessel coil and tissue expander may require special screening."}
• {"criterion_text":"-\tSubject is on chronic immunosuppressive therapy (immunosuppressants or immunotherapy) due to inflammatory or systemic disease."}
• {"criterion_text":"-\tSubject has a history of any autoimmune disease such as systemic lupus erythematosus, Addison's disease, active Crohn's disease, or rheumatoid arthritis."}
• {"criterion_text":"-\tHistory of cardiac tumour or cardiac tumour demonstrated on MRI."}
• {"criterion_text":"-\tPatients in whom revascularisation of the infarct-related artery is technically not possible"}
• {"criterion_text":"-\tCurrent alcohol or drug abuse because of anticipated difficulty in complying with protocol related procedures."}
• {"criterion_text":"-\tAbnormal liver function (GPT > 3 times the upper reference range) and/or haematology (hematocrit < 25%, WBC < 3000, platelets < 100000) studies without a reversible, identifiable cause."}
• {"criterion_text":"-\tSubject has compromised renal function as reflected by a serum creatinine level >3.0 mg/dL (>0.265 mmol/l) or is currently on dialysis."}
• {"criterion_text":"-\tVentricular tachycardia or fibrillation not associated with an acute ischemic episode."}
• {"criterion_text":"-\tSymptomatic ventricular tachyarrhythmia complicating the index infarction."}

Primary endpoints

• {"endpoint_text":"- MACE : •\tDeath and cause of death","definition_or_measurement_approach":"Determined as a component of Major Adverse Cardiac Events (MACE) as specified in the main objective: death and cause of death recorded and adjudicated as part of MACE."}
• {"endpoint_text":"- MACE : •\tRe-admissions and cause of re-admission","definition_or_measurement_approach":"Determined as a component of MACE: re-admissions and cause of re-admission collected from hospital records and used to define MACE."}
• {"endpoint_text":"- MACE : •\tMyocardial infarction","definition_or_measurement_approach":"Determined as a component of MACE: myocardial infarction identified by conventional clinical/ECG/biomarker criteria as part of MACE."}
• {"endpoint_text":"- MACE : •\tTumour formation","definition_or_measurement_approach":"Determined as a component of MACE: tumour formation assessed on screening and follow-up examinations/imaging as part of safety surveillance."}

Secondary endpoints

• {"endpoint_text":"- safety - non-MACE : •\tworsening of heart failure events defined as requiring unscheduled treatment for signs and symptoms of heart failure in an urgent outpatient setting or requiring hospital admission","definition_or_measurement_approach":"Worsening of heart failure events defined explicitly as requiring unscheduled treatment in an urgent outpatient setting or requiring hospital admission; collected from clinical encounters and hospitalization records."}
• {"endpoint_text":"- safety - non - MACE: •\taborted sudden death events, defined as resuscitated sudden death or appropriate Automatic Implantable Cardioverter Defibrillator (AICD) therapy for severe ventricular tachyarrhythmias","definition_or_measurement_approach":"Aborted sudden death events defined as resuscitated sudden death or appropriate AICD therapy for severe ventricular tachyarrhythmias; documented from device reports/clinical records."}
• {"endpoint_text":"- safety - non-MACE : •\tchange in Six-Minute Walk Test from pre-procedure","definition_or_measurement_approach":"Change in Six-Minute Walk Test distance from pre-procedure baseline measured in meters via standardized 6MWT."}
• {"endpoint_text":"- safety - non-safety : •\ttotal days alive out of hospital","definition_or_measurement_approach":"Total days alive and not hospitalized during follow-up, calculated from hospitalization and survival data."}
• {"endpoint_text":"- safety - non - MACE : •\tchanges in NYHA class from pre-procedure and proportion of patients with improved NYHA classification","definition_or_measurement_approach":"Change in NYHA functional class from baseline and proportion improved, assessed by investigator at follow-up visits."}
• {"endpoint_text":"- efficacy : •\tglobal and regional left ventricular function","definition_or_measurement_approach":"Assessed by echocardiogram/MRI/ventriculography as appropriate to measure global and regional LV function (e.g., LVEF, wall motion)."}
• {"endpoint_text":"- efficacy : •\tventricular dimensions","definition_or_measurement_approach":"Ventricular dimensions measured by imaging (echocardiogram/CT/MRI) per standard clinical methods."}
• {"endpoint_text":"- efficacy : •\tmeasurements of infarct size","definition_or_measurement_approach":"Infarct size measured by imaging (MRI delayed enhancement) as per protocol-specified imaging assessments."}

Belgium

Earliest CTIS Part Ii Submission Date

12-07-2025

Latest Decision Or Authorization Date

27-08-2025

Processing Time Days

46

Number Of Sites

2

Number Of Participants

20

Primary sponsor

Full Name

CASC8

Organisation Type

SME

Country Of Registered Address

Belgium