Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 1:06 AM
NCT ID:
NCT06213493
Eligibility Criteria:
1. Left ventricular biopsies from patients with post-ischemic HF
Inclusion Criteria:
* left ventricular reconstruction surgery (SVR)
* ESVI \>35 ml/m2
* EF\<40%
* previous anterior transmural infarction
* age 40-75 years
Exclusion Criteria:
* ESVI \<35 ml/m2
* EF\>40%
* Tempo from E unknown
* Pregnant women
* Patients with genetic diseases
* Patients suffering from malignant neoplasm
* Subjects with collagenopathies
* Subjects undergoing chemo/radiotherapy
* Subjects undergoing prolonged steroid therapy
* Subjects with known active infectious diseases
* Subjects with positive serology for HIV, HBV (not vaccinated), HCV.
2. Patients with ACS and left ventricular dysfunction 12 months after percutaneous angioplasty
Inclusion criteria:
* Age \>18 years
* Patients with ACS (first episode), defined according to the ESC 2017 guidelines \[19\]
* Informed consent to enrollment in the study
Exclusion Criteria:
* Severe heart valve disease or other conditions requiring cardiac surgery
* Previous cardiac surgery including coronary artery bypass grafting
* Total chronic occlusions
* Patients with known hypersensitivity or contraindication to any of the following drugs:
heparin aspirin, clopidogrel, ticlopidine, sirolimus, everolimus.
* Any contraindication to implantation of drug-eluting stents (DES)
* Patients with previous documented myocardial infarction;
* LVEF \<30% before PCI
* Patients in cardiogenic shock
* Patients with advanced STEMI (\> 48 h from the onset of symptoms/Q waves on ECG) or undergoing fibrinolysis;
* Patients with known previous cardiomyopathy with LVEF \< 40%
* Patients suffering from malignant neoplasms or systemic pathologies with a quoad vitam prognosis of less than 1 year;
* Patients suffering from known active infectious diseases;
* Patients who are unable to express valid informed consent at the time of enrollment
* Pregnant women
3. Patients with chronic post-ischemic HF ( recruitment at the Istituti Clinici Scientifici Maugeri Pavia)
Inclusion criteria:
1. All patients admitted to Rehabilitation Cardiology at the Cardiology Department of ICS Maugeri with a diagnosis of chronic heart failure on an ischemic or "acute" basis due to exacerbation of chronic heart failure due to previous ischemia and whose therapies have been optimized at the moment of enlistment.
2. NYHA Class II-III at the time of enlistment;
3. Age over 18 years;
4. Informed consent signed at the time of enrollment in the study.
Exclusion criteria:
1. Denial of informed consent;
2. End-stage renal disease;
3. Presence of ACS, stroke, transient ischemic attack, major cardiovascular surgery, percutaneous coronary angioplasty or carotid angioplasty in the previous 3 months;
4. Patients undergoing cardiac transplantation or on the active list for cardiac transplantation or undergoing LVAD implantation;
5. Presence of hemodynamically significant mitral or aortic valve disease except mitral insufficiency due to ventricular dilatation;
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06213493
Study Brief:
Protocol Section:
NCT06213493