Remote Ischemic Conditioning in Patients Undergoing Prima... | NCT07272408

Studies
Remote Ischemic Conditioning in Patients Undergoing Primary Percutaneous Coronary Intervention

NCT07272408

Sponsor

Helwan University

Status

Completed

Last Update Posted

Dec 9, 2025Actual

Enrollment

2Actual

Phase

Not Applicable

Conditions

Remote
Ischemic Conditioning
Primary Percutaneous Coronary Intervention

Interventions

Remote ischemic conditioning
Normal primary percutaneous coronary intervention

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2022Actual

Primary Completion Date

Dec 30, 2023Actual

Completion Date

Dec 30, 2023Actual

First Submitted Date

Nov 26, 2025

First Submission Date that Met QC Criteria

Nov 26, 2025

First Posted Date

Dec 9, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 26, 2025

Last Update Posted Date

Dec 9, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Remote ischemic conditioning	Procedure	Remote ischemic conditioning (RIC) was applied to those patients.	Remote ischemic conditioning

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Helwan University		Helwan		11795	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Types

Study Protocol

Time Frame

After the end of study for one year.

Access Criteria

The data will be available upon a reasonable request from the corresponding author.

URL

Not provided