RemoteNCT07272408
Remote Ischemic Conditioning in Patients Undergoing Primary Percutaneous Coronary Intervention
A study testing Remote ischemic conditioning and Normal primary percutaneous coronary intervention in people with Remote and Ischemic Conditioning, run by Helwan University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Remote, Ischemic Conditioning, Primary Percutaneous Coronary Intervention
- What is being tested?
- Remote ischemic conditioning and Normal primary percutaneous coronary intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2022to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Remote ischemic conditioning, Normal primary percutaneous coronary intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ischemic conditioningProcedure or surgery
Remote ischemic conditioning (RIC) was applied to those patients.
Normal primary percutaneous coronary interventionProcedure or surgery
Patients followed the standard primary percutaneous coronary intervention pathway.
| Study group | Role | What they receive |
|---|---|---|
| Remote ischemic conditioning | Experimental | Remote ischemic conditioning (RIC) was applied to those patients. Receives: Procedure: Remote ischemic conditioning |
| Normal primary percutaneous coronary intervention | Active comparator | Patients followed the standard primary percutaneous coronary intervention pathway. Receives: Procedure: Normal primary percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac death
Incidence of cardiac death was recorded.
Measured: 1 month post-procedure
Secondary outcomes (4)
Hospitalization for heart failure
Hospitalization for heart failure post-randomization in the intention-to-treat population was assessed.
Measured: 1 month post-procedure
Contrast induced nephropathy
Contrast induced nephropathy was assessed.
Measured: 1 month post-procedure
Incidence of adverse events
Incidence of adverse events was recorded.
Measured: 1 month post-procedure
Renal impairment
Renal impairment was recorded.
Measured: 1 month post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start1 Sep 2022
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RemoteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helwan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Yousry Mousa, Helwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07272408
- Sponsor's protocol ID
- 40-2022
- Status last verified
- Nov 2025
- First submitted
- 26 Nov 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Remote Ischemic Conditioning in Patients Undergoing Primary Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT07272408
- Acronym / sponsor ID
- 40-2022
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Helwan UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote ischemic conditioning | Experimental | Procedure: Remote ischemic conditioningRemote ischemic conditioning (RIC) was applied to those patients. |
| Normal primary percutaneous coronary intervention | Active comparator | Procedure: Normal primary percutaneous coronary interventionPatients followed the standard primary percutaneous coronary intervention pathway. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote ischemic conditioningRemote ischemic conditioning (RIC) was applied to those patients. | Procedure or surgery | Remote ischemic conditioning |
| Normal primary percutaneous coronary interventionPatients followed the standard primary percutaneous coronary intervention pathway. | Procedure or surgery | Normal primary percutaneous coronary intervention |
Primary outcome
Cardiac death
Time frame: 1 month post-procedure
Incidence of cardiac death was recorded.
4 secondary outcomes
Hospitalization for heart failure
Time frame: 1 month post-procedure
Contrast induced nephropathy
Time frame: 1 month post-procedure
Incidence of adverse events
Time frame: 1 month post-procedure
Renal impairment
Time frame: 1 month post-procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Related trials for Remote
Not yet recruiting
Accessible Remote Rehabilitation System for Real-Time Biomechanical Monitoring
Hand Injury Rehabilitation, Postoperative Rehabilitation
Not yet recruiting
Smartphone Camera Measurement of Breathing-Related Heart Rate Variability Compared With ECG in Healthy Adults
Respiratory Sinus Arrhythmia, Heart Rate Variability
RecruitingObservational study
Study of an Oral Fluid Testing Approach
Cannabis Use, Cannabis Intoxication
Not yet recruiting
5G-Enabled Remote Robotic-Assisted Bronchoscopy-Guided Cryoablation for Pulmonary Malignancies
Lung Cancer
Not yet recruiting
Remote Screening and Navigation to Increase Trial Enrollment, INVITE Trial
Bladder Carcinoma, Prostate Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote ischemic conditioning and Normal primary percutaneous coronary intervention in people with Remote and Ischemic Conditioning, run by Helwan University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac death (time frame: 1 month post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.