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Remote Ischemic Conditioning in Patients Undergoing Primary Percutaneous Coronary Intervention

H

Helwan University

Status

Completed

Conditions

Remote
Primary Percutaneous Coronary Intervention
Ischemic Conditioning

Treatments

Procedure: Remote ischemic conditioning
Procedure: Normal primary percutaneous coronary intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT07272408
40-2022

Details and patient eligibility

About

This study aimed to detect the effects of remote ischemic conditioning on infarct size, global contractility, morbidity, mortality, and renal function in patients undergoing primary percutaneous coronary intervention.

Full description

Myocardial infarction (MI) generally refers to segmental (regional) myocardial necrosis, typically endocardial in location, secondary to occlusion of an epicardial artery.

Primary percutaneous coronary intervention (PPCI) is a reperfusion therapy that is carried out in patients who usually have ST-segment elevation MI (STEMI) within a specific time window.

During ischemia, metabolic acidosis occurs due to anaerobic metabolism, and ischemic injury ensues. After restoration of blood supply, reactive oxygen species (ROS) production and local inflammation increase secondary injury.

Enrollment

2 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age more than 18 and less than 75 years old.
  • Both sexes.
  • Patients with new ST-segment elevation at the J-point in V1:V6 leads with the cut-point: ≥ 1mm other than leads V2-V3 where the following cut-points apply: ≥ 2mm in men ≥ 40 years; ≥ 2.5mm in men < 40 years, or ≥ 1.5mm in women regardless of age.
  • Patients with new left bundle branch block (LBBB).

Exclusion criteria

  • ST-segment elevation myocardial infarction (STEMI) with cardiogenic shock.
  • Severe comorbidities (uncontrolled hypertension, morbid obesity, recent cerebrovascular stroke, respiratory failure, sepsis, and stage 4 & 5 malignancy).
  • End-stage renal disease on hemodialysis.
  • Previous coronary artery bypass graft surgery (CABG).
  • Myocardial infarct within the previous 30 days.
  • Multi-vessel coronary artery disease.
  • Failure of culprit vessel recanalization.
  • Conditions precluding use of remote conditioning ie: paresis of upper limb.
  • Life expectancy of less than 1 year due to a non-cardiac pathology.
  • Patients who receive nephrotoxic drugs such as non-steroidal anti-inflammatory drugs and aminoglycosides.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

2 participants in 2 patient groups

Remote ischemic conditioning
Experimental group
Description:
Remote ischemic conditioning (RIC) was applied to those patients.
Treatment:
Procedure: Remote ischemic conditioning
Normal primary percutaneous coronary intervention
Active Comparator group
Description:
Patients followed the standard primary percutaneous coronary intervention pathway.
Treatment:
Procedure: Normal primary percutaneous coronary intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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