Remote Ischemic Conditioning in Patients Undergoing Primary Percutaneous Coronary Intervention

NCT ID: NCT07272408

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2023-12-30

Brief Summary

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.

Detailed 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.

Conditions

Remote; Ischemic Conditioning; Primary Percutaneous Coronary Intervention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Remote ischemic conditioning

Remote ischemic conditioning (RIC) was applied to those patients.

Group Type: EXPERIMENTAL

Remote ischemic conditioning

Intervention Type: PROCEDURE

Remote ischemic conditioning (RIC) was applied to those patients.

Normal primary percutaneous coronary intervention

Patients followed the standard primary percutaneous coronary intervention pathway.

Group Type: ACTIVE_COMPARATOR

Normal primary percutaneous coronary intervention

Intervention Type: PROCEDURE

Patients followed the standard primary percutaneous coronary intervention pathway.

Interventions

Remote ischemic conditioning

Remote ischemic conditioning (RIC) was applied to those patients.

Intervention Type: PROCEDURE

Normal primary percutaneous coronary intervention

Patients followed the standard primary percutaneous coronary intervention pathway.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helwan University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Yousry Mousa

Resident of Cardiology, Helwan University, Helwan, Egypt

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Helwan University

Helwan, , Egypt

Countries

Egypt

Other Identifiers

40-2022

Identifier Type: -

Identifier Source: org_study_id