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

NCT05230966 | Unknown

• 1 other identifier: 2170-29-02/1-21-2
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Myocardial Ischemic-reperfusion Injury

Outcome Measures

Primary Outcomes (10)

• Measurement of the concentration and dynamics of troponin T (Trop T)

  Serum concentrations (ng/ml) will be measured at four time points 0. - after coronary angiography and before PCI; 1. - 1 hour after PCI; 2. - 12 hours after PCI and 3. - 24 hours after PCI.

  24 hour

• Measurement of the concentration and dynamics of cardiac myosin binding protein C (cMyBP-C)

  Serum concentrations (ng/ml) will be measured at four time points 0. - after coronary angiography and before PCI; 1. - 1 hour after PCI; 2. - 12 hours after PCI and 3. - 24 hours after PCI.

  24 hour

• Measurement of the concentration and dynamics of creatine kinase-MB (CK-MB)

  Serum concentrations (ng/ml) will be measured at four time points 0. - after coronary angiography and before PCI; 1. - 1 hour after PCI; 2. - 12 hours after PCI and 3. - 24 hours after PCI.

  24 hour

• Measurement of the concentration and dynamics of oxidation/mitochondrial parameter, hypoxia-induced factor 1 alpha (HIF 1α)

  serum concentrations (pg/ml) will be measured at four time points 0. - after coronary angiography and before PCI; 1. - 1 hour after PCI; 2. - 12 hours after PCI and 3. - 24 hours after PCI.

  24 hour

• Measurement of the concentration and dynamics of metabolic parameter, glycine

  Serum concentrations (μmol/l) will be measured at four time points 0. - after coronary angiography and before PCI; 1. - 1 hour after PCI; 2. - 12 hours after PCI and 3. - 24 hours after PCI.

  24 hour

• Measurement of the concentration and dynamics of metabolic parameter, kynurenine

  Serum concentrations (μmol/l) will be measured at four time points 0. - after coronary angiography and before PCI; 1. - 1 hour after PCI; 2. - 12 hours after PCI and 3. - 24 hours after PCI.

  24 hour

• Measurement of the concentration and dynamics of metabolic parameter, succinate

  Serum concentrations (μM) will be measured at four time points 0. - after coronary angiography and before PCI; 1. - 1 hour after PCI; 2. - 12 hours after PCI and 3. - 24 hours after PCI.

  24 hour

• Measurement of the concentration and dynamics of immunological parameter, interleukin 1 beta (IL-1 beta)

  Serum concentrations (pg/ml) will be measured at four time points 0. - after coronary angiography and before PCI; 1. - 1 hour after PCI; 2. - 12 hours after PCI and 3. - 24 hours after PCI.

  24 hour

• Measurement of the concentration and dynamics of immunological parameter, transforming growth factor beta (TGF beta)

  Serum concentrations (ng/ml) will be measured at four time points 0. - after coronary angiography and before PCI; 1. - 1 hour after PCI; 2. - 12 hours after PCI and 3. - 24 hours after PCI.

  24 hour

• Measurement of the concentration and dynamics of immunological parameter, monocyte chemoattraction protein 1 (MCP-1)

  Serum concentrations (pg/ml) will be measured at four time points 0. - after coronary angiography and before PCI; 1. - 1 hour after PCI; 2. - 12 hours after PCI and 3. - 24 hours after PCI.

  24 hour

Secondary Outcomes (5)

• The changes in serum values of immunometabolic parameters and creatine kinase-MB

  24 hour

• The changes in serum values of immunometabolic parameters and troponin T

  24 hour

• The changes in serum values of immunometabolic parameters and left heart ejection fraction

  7 day

• The changes in serum values of immunometabolic parameters in PCI groups and angina pectoris (AP) group

  24 hour

• The changes in serum values of immunometabolic parameters in PCI groups and the group of healthy volunteers

  24 hour

Study Arms (5)

Group 1- angina pectoris

NO INTERVENTION

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

Group 2 - angina pectoris + STEMI+ PCI

NO INTERVENTION

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 3 - without angina pectoris + STEMi + RIC + PCI

ACTIVE COMPARATOR

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)

Device: Remote Ischemic Conditioning (RIC)

Group 4 - without angina pectoris + STEMI + PCI

NO INTERVENTION

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 5 - healthy + RIC

ACTIVE COMPARATOR

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

Device: Remote Ischemic Conditioning (RIC)

Interventions

Remote Ischemic Conditioning (RIC) 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 3 - without angina pectoris + STEMi + RIC + PCI; Group 5 - healthy + RIC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For group 1:
• Acute coronary syndrome; angina pectoris (chest pain with negative troponin T with or without changes in electrocardiographic findings);
• Monovascular disease, preocclusive stenosis with TIMI(thrombolysis in myocardial infarction) \> 1 on the left main or anterior descending branch of the left coronary artery
• Visually estimated diameter of the epicardial coronary artery from 2.5 mm to 4.0 mm
• For group 2:
• 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
• Symptoms of angina pectoris preceding acute myocardial infarction
• Monovascular disease, occlusion or preocclusive stenosis of the anterior descending branch of the left coronary artery with TIMI \<1 flow in STEMI;
• After opening the artery and setting the stent TIMI\> 2 flow
• Visually estimated epicardial coronary artery diameter up to 2.5 mm to 4.0 mm
• For groups 3 and 4:
• 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
• No symptoms of angina pectoris preceding acute myocardial infarction
• Monovascular disease, occlusion or preocclusive stenosis of the anterior descending branch of the left coronary artery with TIMI \<1 flow in STEMI;
• After opening the artery and stent placement TIMI\> 2 flow

You may not qualify if:

• Cardiac arrest before or after PCI;
• Cardiogenic shock;
• Previous myocardial infarction or revascularization of the heart;
• Anginal pain before the onset of STEMI in patients to be subjected to RIC;
• Patients with end-stage renal or hepatic disease, diabetics with developed micro and macrovascular complications, oncology patients;
• Significant collaterals in the area of the occluded artery (Rentrop gradus\> 1);
• Previous use of nitrates and corticosteroids;
• Pregnant or breastfeeding women;
• Iodine allergy (contrast media);
• Increase in body temperature \> 37.5 ° C
• 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

Sponsors & Collaborators

• Clinical Hospital Center Rijeka: lead

Related Publications (4)

• Hausenloy DJ, Yellon DM. Myocardial ischemia-reperfusion injury: a neglected therapeutic target. J Clin Invest. 2013 Jan;123(1):92-100. doi: 10.1172/JCI62874. Epub 2013 Jan 2.

  PMID: 23281415 BACKGROUND

• Hausenloy DJ. Cardioprotection techniques: preconditioning, postconditioning and remote conditioning (basic science). Curr Pharm Des. 2013;19(25):4544-63. doi: 10.2174/1381612811319250004.

  PMID: 23270554 BACKGROUND

• Han X, Jeong MH, Won J, Kim Y, Kim MC, Sim DS, Hong YJ, Kim JH, Ahn Y. Impact of Previous Angina on Clinical Outcomes in ST-Elevation Myocardial Infarction Underwent Percutaneous Coronary Intervention. Chonnam Med J. 2020 May;56(2):136-143. doi: 10.4068/cmj.2020.56.2.136. Epub 2020 May 25.

  PMID: 32509561 BACKGROUND

• Heusch G, Botker HE, Przyklenk K, Redington A, Yellon D. Remote ischemic conditioning. J Am Coll Cardiol. 2015 Jan 20;65(2):177-95. doi: 10.1016/j.jacc.2014.10.031.

  PMID: 25593060 BACKGROUND

MeSH Terms

Conditions

Myocardial Reperfusion Injury

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Myocardial Ischemia; Vascular Diseases; Reperfusion Injury; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Koraljka Benko, MD

  CHC Rijeka; Croatia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Koraljka Benko, MD

CONTACT

+38598462387; bkoraljka@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: February 9, 2022
• Study Start: February 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: March 2, 2023
• Last Updated: February 9, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share