The patients suffering form acute transmural myocardial infarction and treated with percutaneous transluminal coronary angioplasty will be included in the study. After the recanalisation of occluded artery, the reperfusion injury develops and the regeneration of ischemic tissue is impaired. The reactive oxygen species are partly responsible for reperfusion injury pathogenesis.
Conditions
Interventions
Product Name: Nitrogen-oxygen-hydrogen gas mixture (58%-40%-2%, respectively) for inhalation
Pharmaceutical Form: Medicinal gas, compressed
INN or Proposed INN: OXYGEN
Other descriptive name: oxygen g
Sponsors
University Hospital Hradec Kralove
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The patients, aged 50-75 years (postmenopausal women only), suffering from acute myocardial infarction, transmural, originating from large vessel damage, will be included in the study. There cannot be any previous myocardial infarction, any previous cardiosurgery or cardiogenic shock present (Kyllip 1-3). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: Cardiogenic shock development, participation in another study, previus cardiosurgery, impossibility of primary PCI, diabetic decompensation, serious anamnestic nephropathy, serius anamnestic hepatopathy, cancer disease at present or previous five years, other serious comorbidities.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Due to the fast growing body of information regarding positive effects of oxygen - hydrogen mixtures in various clinical conditions, it is necessary to evaluate its positive potential in the case of acute coronary angioplasty, where its fast diffusibility is especially profitable.;Secondary Objective: Althouth there are not any available data regarding hydrogen toxicity and 2% concentration is low, the safety of oxygen - hydrogen mixture must be validated in the situation of acute coronary angioplasty.;Primary end point(s): The primary end-point is the effectivity evaluation of inhalational application of oxygen-hydrogen mixture against conventional oxygenotherapy on residual myocardial damage.;Timepoint(s) of evaluation of this end point: Visit 1: Patient iclusion into the study (day 0) Visit 2: The end of coronary angioplasty (day 0) Visit 3:Admission to ICU (day 0) Visit 4: The morning of following day (day 1)Visit 5: The morning of following day (day 2) Visit 6: The day of patient discharge. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary end-point is the safety evaluation of inhalational application of oxygen(40%) -hydrogen (2%) mixture during coronary angioplasty.;Timepoint(s) of evaluation of this end point: Visit 1: Patient iclusion into the study (day 0) Visit 2: The end of coronary angioplasty (day 0) Visit 3:Admission to ICU (day 0) Visit 4: The morning of following day (day 1)Visit 5: The morning of following day (day 2) Visit 6: The day of patient discharge. | — |
Countries
Czech Republic
Contacts
Public ContactCenter for Research and Development
University Hospital Hradec Kralove
Outcome results
None listed