Remote Ischemic Conditioning in Patients Undergoing Primary Percutaneous Coronary Intervention

Impact of Remote Ischemic Conditioning in Patients Undergoing Primary Percutaneous Coronary Intervention

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.

Study Overview

• Status: Completed
• Conditions: Primary Percutaneous Coronary Intervention; Ischemic Conditioning; Remote
• Intervention / Treatment: Procedure: Remote ischemic conditioning; Procedure: Normal 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.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Helwan, Egypt, 11795
    • Helwan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remote ischemic conditioning; Remote ischemic conditioning (RIC) was applied to those patients.	Procedure: Remote ischemic conditioning; Remote ischemic conditioning (RIC) was applied to those patients.
Active Comparator: Normal primary percutaneous coronary intervention; Patients followed the standard primary percutaneous coronary intervention pathway.	Procedure: Normal primary percutaneous coronary intervention; Patients followed the standard primary percutaneous coronary intervention pathway.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac death	Incidence of cardiac death was recorded.	1 month post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospitalization for heart failure	Hospitalization for heart failure post-randomization in the intention-to-treat population was assessed.	1 month post-procedure
Contrast induced nephropathy	Contrast induced nephropathy was assessed.	1 month post-procedure
Incidence of adverse events	Incidence of adverse events was recorded.	1 month post-procedure
Renal impairment	Renal impairment was recorded.	1 month post-procedure

Collaborators and Investigators

• Sponsor: Helwan University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): December 30, 2023
• Study Completion (Actual): December 30, 2023

Study Registration Dates

• First Submitted: November 26, 2025
• First Submitted That Met QC Criteria: November 26, 2025
• First Posted (Estimated): December 9, 2025

Study Record Updates

• Last Update Posted (Estimated): December 9, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 40-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No