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Status unknownNCT05230966Updated Feb 9, 2022

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

An interventional study of Remote Ischemic Conditioning (RIC) in Myocardial Ischemic-reperfusion Injury, sponsored by Clinical Hospital Center Rijeka. Status unknown. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-09.

Sponsored by Clinical Hospital Center Rijeka · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Jan 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Myocardial Ischemic-reperfusion Injury
03

In context

Myocardial Infarction

2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.

This study's planned enrollment of 25 is below the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

Clinical Hospital Center Rijeka is the lead sponsor of 19 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
25 participants (estimated)

Study arms

  • No intervention
    Group 1- angina pectoris

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

  • No intervention
    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.

  • Active comparator
    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)

    Device: Remote Ischemic Conditioning (RIC)

  • No intervention
    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.

  • Active comparator
    Group 5 - healthy + RIC

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

    Device: Remote Ischemic Conditioning (RIC)

Interventions

  • DeviceRemote 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 24 hour

  2. 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.

    Time frame: 24 hour

  3. 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.

    Time frame: 24 hour

  4. 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.

    Time frame: 24 hour

  5. 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.

    Time frame: 24 hour

  6. 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.

    Time frame: 24 hour

  7. 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.

    Time frame: 24 hour

  8. 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.

    Time frame: 24 hour

  9. 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.

    Time frame: 24 hour

  10. 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.

    Time frame: 24 hour

Secondary outcomes

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

    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.

    Time frame: 24 hour

  2. The changes in serum values of immunometabolic parameters and troponin T

    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

    Time frame: 24 hour

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

    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 (%).

    Time frame: 7 day

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

    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).

    Time frame: 24 hour

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

    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.

    Time frame: 24 hour

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 23281415 ↗
  • Hausenloy DJ. Cardioprotection techniques: preconditioning, postconditioning and remote conditioning (basic science). Curr Pharm Des. 2013;19(25):4544-63. doi: 10.2174/1381612811319250004. PubMed 23270554 ↗
  • 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. PubMed 32509561 ↗
  • 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. PubMed 25593060 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05230966
Lead sponsor
Clinical Hospital Center Rijeka
Responsible party
Koraljka Benko (M.D., Clinical Hospital Center Rijeka) — Principal investigator
First posted
Feb 9, 2022
Start date
Feb 1, 2022 (estimated)
Primary completion
Dec 1, 2022 (estimated)
Completion
Mar 2, 2023 (estimated)
Last update
Feb 9, 2022

Study contacts

Koraljka Benko, MD
Contact
bkoraljka@yahoo.com
+38598462387
Koraljka Benko, MD
principal investigator · CHC Rijeka; Croatia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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