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

28. Januar 2022 aktualisiert von: Koraljka Benko, Clinical Hospital Center Rijeka

Immunometabolic Pattern of Intermittent Hypoxia as a Protective Mechanism Against Lethal Reperfusion Injury in Patients With ST-segment Elevation Myocardial Infarction

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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Voraussichtlich)

25

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Sonstiges
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Kein Eingriff: Group 1- angina pectoris
Patients with acute coronary syndrome; angina pectoris (chest pain with negative troponin T with or without changes in electrocardiographic findings);
Kein Eingriff: 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.
Aktiver Komparator: 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)
Gerät: 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.
Kein Eingriff: 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.
Aktiver Komparator: Group 5 - healthy + RIC
healthy volunteers of the same age and sex, whose samples will be taken after the RIC procedure
Gerät: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Measurement of the concentration and dynamics of troponin T (Trop T)
Zeitfenster: 24 hour
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)
Zeitfenster: 24 hour
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)
Zeitfenster: 24 hour
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)
Zeitfenster: 24 hour
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
Zeitfenster: 24 hour
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
Zeitfenster: 24 hour
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
Zeitfenster: 24 hour
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)
Zeitfenster: 24 hour
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)
Zeitfenster: 24 hour
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)
Zeitfenster: 24 hour
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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
The changes in serum values of immunometabolic parameters and creatine kinase-MB
Zeitfenster: 24 hour
The data of immunometabolic parameters at baseline and during follow up period (measured at 0, 1, 12 and 24 hours after the intervention) in three groups of patients with PCI will be compared with a degree of tissue damage creatine kinase-MB.
24 hour
The changes in serum values of immunometabolic parameters and troponin T
Zeitfenster: 24 hour
The data of immunometabolic parameters at baseline and during follow up period (measured at 0, 1, 12 and 24 hours after the intervention) in three groups of patients with PCI will be compared with a degree of tissue damage troponin T
24 hour
The changes in serum values of immunometabolic parameters and left heart ejection fraction
Zeitfenster: 7 day
The data of immunometabolic parameters at baseline and during follow up period (measured at 0, 1, 12 and 24 hours after the intervention) in three groups of patients with PCI will be compared with functional assessment of the heart muscle, ejection fraction (%).
7 day
The changes in serum values of immunometabolic parameters in PCI groups and angina pectoris (AP) group
Zeitfenster: 24 hour
The data of immunometabolic parameters at baseline and during follow up period (measured at 0, 1, 12 and 24 hours after the intervention) in three groups of patients with PCI will be compared with the data of patients diagnosed with angina pectoris (AP).
24 hour
The changes in serum values of immunometabolic parameters in PCI groups and the group of healthy volunteers
Zeitfenster: 24 hour
The data of immunometabolic parameters at baseline and during follow up period (measured at 0, 1, 12 and 24 hours after the intervention) in three groups of patients with PCI will be compared with the group of healthy volunteers in whom the RIC method was used.
24 hour

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Clinical Hospital Center Rijeka

Ermittler

  • Hauptermittler: Koraljka Benko, MD, CHC Rijeka; Croatia

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Voraussichtlich)

1. Februar 2022

Primärer Abschluss (Voraussichtlich)

1. Dezember 2022

Studienabschluss (Voraussichtlich)

2. März 2023

Studienanmeldedaten

Zuerst eingereicht

12. Januar 2022

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

28. Januar 2022

Zuerst gepostet (Tatsächlich)

9. Februar 2022

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

9. Februar 2022

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

28. Januar 2022

Zuletzt verifiziert

1. Januar 2022

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2170-29-02/1-21-2

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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

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