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:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-24 @ 6:59 PM
NCT ID:
NCT03660657
Eligibility Criteria:
Inclusion Criteria:
* Adults with ischemic heart disease, Functional Class III-IV from the NYHA, with symptoms in spite of maximal conventional medical treatment and no suitable to further percutaneous or surgical procedures.
* It should be required clinical diagnosis by the Cardiology Department and confirmation by cardiac catheterization with coronary angiography.
* Ejection Fraction \< 40%
* Patients who have signed and dated the study 's specific informed consent.
* Before enrollment, women of childbearing potential should obtain a negative result in the serum or urine pregnancy test at the screening visit, and accept the use of appropriate contraceptive methods at least from the 14 days prior to the first dose of the study drug. up to 14 days after the last one.
Exclusion Criteria:
* Age \< 18 or \> 85 years old.
* Severe valve disease and/or dynamic left ventricular outflow tract obstruction.
* Pregnancy at the time of enrollment.
* Limited walking ability due to neurologic or orthopedic impairments of the legs
* Those who are incapable to fill in the scales used to measure the quality of life variables
* Cerebral vascular accident (CVA or Transient Ischemic Attack (TIA) within the previous 3 months or carotid stenosis \> 80%.
* Acute myocardial infarction (AMI), Percutaneous coronary intervention (PCI) or transmyocardial laser revascularization (TMR or PMR) within the previous 3 months.
* Hemodynamically or clinically unstable patients.
* Severe or limiting pulmonary diseases.
* Specific liver enzymes \[Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) \> 5 times the upper limit of normal
* Increased creatinine \> 3 times the upper limit of normal or Glomerular Filtration Rate (GFR) \< 25 ml/min or who are on chronic renal dialysis.
* Severe peripheral vascular disease with rest pain or significant chronic wounds.
Uncontrolled cancer disease or severe active systemic infection or HIV.
* Life expectancy \< 4 months
* Contraindication or disability for rectal ozone administration or to attend scheduled treatments.
* Known allergy to ozone.
* Patients who do not meet all the inclusion criteria.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT03660657
Study Brief:
Protocol Section:
NCT03660657