Immunometabolic Pattern of Intermittent Hypoxia During ST-segment Elevation Myocardial Infarction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2023-03-02

Brief Summary

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The aim of this study is to characterize the protective pattern of intermittent hypoxia, angina pectoris and remote ischemic conditioning, in reperfusion injury by determining and monitoring the plasma immunometabolic parameters of patients with STEMI. This could contribute to better understanding of this phenotypic pattern with translation into clinical practice.

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Detailed Description

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In acute myocardial infarction with ST segment elevation (STEMI), lethal reperfusion injury of the myocardium, caused by percutaneous coronary intervention (PCI), represents additional and irreversible damage due to ischemic heart muscle reperfusion that contributes to the final size of the infarct zone by up to 50%. The size of the infarcted area is the major determinant for the long-term prognosis and heart failure progression in patients with STEMI. Cardioprotection from ischemic - reperfusion myocardial injury (MIRI) can be regulated by its own innate physiological adaptive mechanisms like intermittent hypoxia achieved by the method of conditioning that includes short sublethal ischemic and reperfusion episodes.

The known natural clinical equivalent of intermittent hypoxia and the starting point in understanding the underlying mechanism is angina pectoris (AP).

Intermittent hypoxia is a protective mechanism against heart ischemic-reperfusion injury with reduced tissue damage and consequently better outcome in patients with STEMI. For the purpose of this work, a cardioprotective pattern was defined that includes immunometabolic factors as parameters for assessing the state of intermittent hypoxia on which the success of the application of the method of remote ischemic conditioning (RIC) is based.

Conditions

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Myocardial Ischemic-reperfusion Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group 1- angina pectoris

Patients with acute coronary syndrome; angina pectoris (chest pain with negative troponin T with or without changes in electrocardiographic findings);

Group Type NO_INTERVENTION

No interventions assigned to this group

Group 2 - angina pectoris + STEMI+ PCI

Patients with acute myocardial infarction with ST-segment elevation, \< 6 hours from the onset of chest pain and preceding symptoms of angina pectoris with primary percutaneous coronary intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Group 3 - without angina pectoris + STEMi + RIC + PCI

Patients with acute myocardial infarction with ST-segment elevation, \< 6 hours from the onset of chest pain and without preceding symptoms of angina pectoris with primary percutaneous coronary intervention during which it's carried out remote ischemic conditioning (RIC)

Group Type ACTIVE_COMPARATOR

Remote Ischemic Conditioning (RIC)

Intervention Type DEVICE

RIC is a non-invasive method that achieves a state of intermittent hypoxia, and is performed by inflating the cuff of the pressure gauge on the left upper arm to 200 mmHg in 4 episodes of five-minute ischemia and reperfusion alternately for 45 minutes.

Group 4 - without angina pectoris + STEMI + PCI

Patients with acute myocardial infarction with ST-segment elevation, \< 6 hours from the onset of chest pain and without preceding symptoms of angina pectoris with primary percutaneous coronary intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Group 5 - healthy + RIC

healthy volunteers of the same age and sex, whose samples will be taken after the RIC procedure

Group Type ACTIVE_COMPARATOR

Remote Ischemic Conditioning (RIC)

Intervention Type DEVICE

RIC is a non-invasive method that achieves a state of intermittent hypoxia, and is performed by inflating the cuff of the pressure gauge on the left upper arm to 200 mmHg in 4 episodes of five-minute ischemia and reperfusion alternately for 45 minutes.

Interventions

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Remote Ischemic Conditioning (RIC)

RIC is a non-invasive method that achieves a state of intermittent hypoxia, and is performed by inflating the cuff of the pressure gauge on the left upper arm to 200 mmHg in 4 episodes of five-minute ischemia and reperfusion alternately for 45 minutes.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes