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 @ 4:34 PM
Ignite Modification Date:
2025-12-24 @ 4:34 PM
NCT ID:
NCT05230966
Eligibility Criteria:
Inclusion Criteria:
For group 1:
1. Acute coronary syndrome; angina pectoris (chest pain with negative troponin T with or without changes in electrocardiographic findings);
2. Monovascular disease, preocclusive stenosis with TIMI(thrombolysis in myocardial infarction) \> 1 on the left main or anterior descending branch of the left coronary artery
3. Visually estimated diameter of the epicardial coronary artery from 2.5 mm to 4.0 mm
For group 2:
1. Acute myocardial infarction with ST-segment elevation (ST-segment elevation\> 0.1 mV in two or more leads, or\> 0.2 mV in V1-V3) \<6 hours from the onset of chest pain
2. Symptoms of angina pectoris preceding acute myocardial infarction
3. Monovascular disease, occlusion or preocclusive stenosis of the anterior descending branch of the left coronary artery with TIMI \<1 flow in STEMI;
4. After opening the artery and setting the stent TIMI\> 2 flow
5. Visually estimated epicardial coronary artery diameter up to 2.5 mm to 4.0 mm
For groups 3 and 4:
1. Acute myocardial infarction with ST-segment elevation (ST-segment elevation\> 0.1 mV in two or more leads, or\> 0.2 mV in V1-V3) \<6 hours from the onset of chest pain
2. No symptoms of angina pectoris preceding acute myocardial infarction
3. Monovascular disease, occlusion or preocclusive stenosis of the anterior descending branch of the left coronary artery with TIMI \<1 flow in STEMI;
4. After opening the artery and stent placement TIMI\> 2 flow
5. Visually estimated diameter of the epicardial coronary artery from 2.5 mm to 4.0 mm
For all groups:
1. Age of patients over 18 years
2. Signed written informed consent to be included in the survey
Exclusion Criteria:
1. Cardiac arrest before or after PCI;
2. Cardiogenic shock;
3. Previous myocardial infarction or revascularization of the heart;
4. Anginal pain before the onset of STEMI in patients to be subjected to RIC;
5. Patients with end-stage renal or hepatic disease, diabetics with developed micro and macrovascular complications, oncology patients;
6. Significant collaterals in the area of the occluded artery (Rentrop gradus\> 1);
7. Previous use of nitrates and corticosteroids;
8. Pregnant or breastfeeding women;
9. Iodine allergy (contrast media);
10. Increase in body temperature \> 37.5 ° C
11. Participation in another clinical trial
Randomly selected (coin toss) patients will be randomized to group 3 and 4, respectively, for percutaneous coronary intervention with or without RIC
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05230966
Study Brief:
Protocol Section:
NCT05230966