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 @ 5:00 AM
Ignite Modification Date:
2025-12-25 @ 5:00 AM
NCT ID:
NCT05809518
Eligibility Criteria:
Inclusion Criteria:
* Multi vascular lesions of the coronary arteries according to coronary angiography;
* Heart valve damage was confirmed by heart ultrasound, which is subject to surgical correction (aortic stenosis of III degree with a gradient on the aortic valve of more than 42 mmHg, aortic insufficiency III, mitral valve stenosis II-III, mitral regurgitation II-III)
* Patient consent to participate in the study;
* Women who have a negative pregnancy test and use effective contraception throughout the study and for 3 weeks after its completion, or women who are unable to have children (women who have undergone a hysterectomy (removal of the uterus) or tubal ligation, women with a clinical diagnosis of infertility) or are menopausal for more than 1 year (absence of menstruation for at least 12 months). Adequate methods of contraception include: surgical sterilization, double barrier method of contraception, local contraception;
Exclusion Criteria:
* Refusal to participate;
* Hypersensitivity to propofol, dexmedetomidine;
* Prolonged mechanical ventilation in case of surgical complications (bleeding, inadequate perfusion of the myocardium);
* Occurred ischemic stroke;
* History of the ischemic stroke;
* History of the neurodegenerative diseases;
* History of the mental disorders;
* Use of neuroleptics, antidepressants for the last 5 years;
* History of the cardiac surgery in the past;
* Patients with chronic pulmonary disease (GOLD 3-4)
* Patients with asthma (moderate or severe),
* Participation in any other clinical trial;
* Gastric or duodenal ulcer with risk of bleeding;
* Chronic renal failure (ClCr less than 50 ml / h)
* Acute renal failure that occurred during surgery (ClCr less than 50 ml / h, or a decrease in the rate of diuresis to 0.1 ml / h in the first 4 hours after surgery and does not respond to diuretic therapy)
* Chronic hepatic insufficiency if there are laboratory signs of hypo coagulation without the use of anticoagulant therapy (INR\> 1.5)
* If the patient has not stopped taking anticoagulants or antiplatelet agents in the preoperative period: warfarin 5 days before surgery, clopidogrel 5-7 days before surgery, xarelto / pradaxa 3 days before surgery),
* History of the hematological disease;
* Alcohol abuse in the anamnesis (3-4 times a week).
* Condition after chemotherapy; Pregnancy, lactation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05809518
Study Brief:
Protocol Section:
NCT05809518