ST Segment Elevation Myocardial Infarction (STEMI)Phase 3NCT06847568
The Investigator Administers Intracoronary Adrenaline Via the Catheter in STEMI Patients During Primary PCI, After Flow Restoration and Before Stenting, and Studies Its Effect in Prevention of No Reflow
A Phase 3 study testing Adrenaline in people with ST Segment Elevation Myocardial Infarction (STEMI) and No Reflow Phenomenon, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this work is to study the role of intracoronary adrenaline administration as a preventive tool for no reflow in patients undergoing primary PCI. The main question it aims to answer is: Do prohylcatic intrcoronary adrenaline reduce the incidence of no reflow without increaing risk of arrhythmia in primary… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST Segment Elevation Myocardial Infarction (STEMI), No Reflow Phenomenon
- What is being tested?
- Adrenaline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2024to 30 Apr 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are 18 years or older
- Patients presenting with acute coronary syndrome with ECG criteria diagnostic of STEMI (according to the universal definition of myocardial infarction) within 12 hours from the onset of symptoms and treated by successful primary PCI.
Who cannot join
- Age < 18 years
- Pregnant females.
- Patients refused to give consent.
- Patients who had normal coronary angiography.
- Patients who had CTO lesions.
- Patients who have SCAD.
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- Patients who developed dissection or mechanical complication during the procedure.
- Patients presenting with cardiogenic shock.
- Cardiomyopathies
- Contraindications to epinephrine as HTN with SBP >180 mmHg or DBP>110 mmHg, clinically significant arrhythmia (Atrial fibrillation with rapid ventricular rate, ventricular tachycardia, or ventricular fibrillation) prior to PCI, known allergy to epinephrine.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mostafa Abdallah Khalifa, Master cardiology contact
Egypt1 site, 1 recruiting
- Recruiting
Faculty of medicine Ain Shams Univesity
Cairo
Khaled Aly, Associate professor, 201003593088, Dr.khaled.aly@med.asu.edu.eg
About this study
Official title: Role of Catheter Administered Intracoronary Epinephrine in Prevention of No-Reflow in STEMI Patients Undergoing Primary Percutaneous Coronary Intervention
The aim of this work is to study the role of intracoronary adrenaline administration as a preventive tool for no reflow in patients undergoing primary PCI.
The main question it aims to answer is:
Read more
Do prohylcatic intrcoronary adrenaline reduce the incidence of no reflow without increaing risk of arrhythmia in primary PCI?
The procedure will be performed by expert operators. All patients will receive the guidelines-directed recommendations of intervention of STEMI patients.
Study group wil receive Intracoronary 10 mcg adrenaline via the guiding catheter after restoration of epicardial coronary flow of the culprit vessel and achievement of TIMI I flow either after wiring and/or passage of a deflated balloon and/or PTCA with a small balloon, and/or use of thrombus aspiration and before stenting.
All steps in the Cath-lab will be described in detail:
The primary end points will be improvement in coronary flow, as assessed by TIMI (Thrombolysis in Myocardial Infarction) flow, and myocardial blush.
Secondary end points will be in-hospital mortality and major adverse cardiac events.
- Being tested
- Adrenaline
- Keywords
- STEMI, No-reflow, Adrenaline, Prophylaxis
- Medical subject headings
- ST Elevation Myocardial Infarction, No-Reflow Phenomenon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdrenalineDrug
Also called Epinephrine
Intracoronary 10 mcg adrenaline will be given via the guiding catheter in study group after restoration of epicardial coronary flow of the culprit vessel and achievement of TIMI I flow either after wiring and/or passage of a deflated balloon and/or PTCA with a small balloon, and/or use of thrombus aspiration and before stenting.
| Study group | Role | What they receive |
|---|---|---|
| Study (Adrenaline) | Active comparator | This group will receive the all guidelines-directed recommendations of intervention in STEMI patients.
Intracoronary 10 mcg adrenaline will be given via the guiding catheter in study group after restoration of epicardial coronary flow of the culprit vessel and achievement of TIMI I flow either after wiring and/or passage of a deflated balloon and/or PTCA with a small balloon, and/or use of thrombus aspiration and before stenting. Receives: Drug: Adrenaline |
| Control | No intervention | This group will receive the standards of care , all guidelines-directed recommendations of intervention in STEMI patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
No-relow
The primary end points will be improvement in coronary flow, as assessed by TIMI (Thrombolysis in Myocardial Infarction) flow
Thrombolysis in Myocardial Infarction risk score (TIMI) flow grading system as following:
- TIMI 0 = No ante-grade flow beyond the point of occlusion.
- TIMI 1 = Faint ante-grade flow beyond the point of occlusion with incomplete filling of the distal vascular bed.
- TIMI 2 = Delayed or sluggish ante-grade flow with complete filling of the distal vascular beds.
- TIMI 3 = Normal flow with complete filling of the distal vascular bed
Coronary no-reflow (CNR) is diagnosed immediately after PCI when post-procedural angiographic TIMI flow is < 3
Measured: 1 year up to 2 years
No-relow
The primary end points will be improvement in coronary flow, as assessed by myocardial blush grade.
Myocardial blush grade (MBG) is defined as:
- MBG 0 = No myocardial blush or contrast density.
- MBG 1 = Minimal myocardial blush or contrast density.
- MBG 2 = Moderate myocardial blush or contrast density but less than that obtained during angiography of a contralateral or ipsi-lateral non-infarct-related coronary artery.
- MBG 3 = Normal myocardial blush or contrast density, comparable with that obtained during angiography of a contralateral or ipsilateral non-infarct-related coronary artery
Coronary no-reflow (CNR) is diagnosed immediately after PCI when post-procedural angiographic MBG is 0 or 1
Measured: 1 year up to 2 years
Secondary outcomes (1)
MACE
Secondary end points will be major adverse cardiac events.
Measured: 1 year up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start1 Apr 2024
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST Segment Elevation Myocardial Infarction (STEMI)Studies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa AbdAllah Khalifa, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06847568
- Sponsor's protocol ID
- FMASU MD48/2024
- Status last verified
- Mar 2025
- First submitted
- 16 Feb 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Catheter Administered Intracoronary Epinephrine in Prevention of No-Reflow in STEMI Patients Undergoing Primary Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT06847568
- Acronym / sponsor ID
- FMASU MD48/2024
- Keywords
- STEMI, No-reflow, Adrenaline, Prophylaxis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 26 Feb 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.
The aim of this work is to study the role of intracoronary adrenaline administration as a preventive tool for no reflow in patients undergoing primary PCI.
The main question it aims to answer is:
Do prohylcatic intrcoronary adrenaline reduce the incidence of no reflow without increaing risk of arrhythmia in primary PCI?
The procedure will be performed by expert operators. All patients will receive the guidelines-directed recommendations of intervention of STEMI patients.
Study group wil receive Intracoronary 10 mcg adrenaline via the guiding catheter after restoration of epicardial coronary flow of the culprit vessel and achievement of TIMI I flow either after wiring and/or passage of a deflated balloon and/or PTCA with a small balloon, and/or use of thrombus aspiration and before stenting.
All steps in the Cath-lab will be described in detail:
The primary end points will be improvement in coronary flow, as assessed by TIMI (Thrombolysis in Myocardial Infarction) flow, and myocardial blush.
Secondary end points will be in-hospital mortality and major adverse cardiac events.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study (Adrenaline) | Active comparator | Drug: AdrenalineThis group will receive the all guidelines-directed recommendations of intervention in STEMI patients. Intracoronary 10 mcg adrenaline will be given via the guiding catheter in study group after restoration of epicardial coronary flow of the culprit vessel and achievement of TIMI I flow either after wiring and/or passage of a deflated balloon and/or PTCA with a small balloon, and/or use of thrombus aspiration and before stenting. |
| Control | No intervention | –This group will receive the standards of care , all guidelines-directed recommendations of intervention in STEMI patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who are 18 years or older
- Patients presenting with acute coronary syndrome with ECG criteria diagnostic of STEMI (according to the universal definition of myocardial infarction) within 12 hours from the onset of symptoms and treated by successful primary PCI.
Key exclusion criteria (10 listed)
- Age < 18 years
- Pregnant females.
- Patients refused to give consent.
- Patients who had normal coronary angiography.
- Patients who had CTO lesions.
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 |
|---|---|---|
| AdrenalineAlso: EpinephrineIntracoronary 10 mcg adrenaline will be given via the guiding catheter in study group after restoration of epicardial coronary flow of the culprit vessel and achievement of TIMI I flow either after wiring and/or passage of a deflated balloon and/or PTCA with a small balloon, and/or use of thrombus aspiration and before stenting. | Drug | Study (Adrenaline) |
Primary outcome
No-relow
Time frame: 1 year up to 2 years
The primary end points will be improvement in coronary flow, as assessed by TIMI (Thrombolysis in Myocardial Infarction) flow Thrombolysis in Myocardial Infarction risk score (TIMI) flow grading system as following: * TIMI 0 = No ante-grade flow beyond the point of occlusion. * TIMI 1 = Faint ante-grade flow beyond the point of occlusion with incomplete filling of the distal vascular bed. * TIMI 2 = Delayed or sluggish ante-grade flow with complete filling of the distal vascular beds. * TIMI 3 = Normal flow with complete filling of the distal vascular bed Coronary no-reflow (CNR) is diagnosed immediately after PCI when post-procedural angiographic TIMI flow is < 3
No-relow
Time frame: 1 year up to 2 years
The primary end points will be improvement in coronary flow, as assessed by myocardial blush grade. Myocardial blush grade (MBG) is defined as: * MBG 0 = No myocardial blush or contrast density. * MBG 1 = Minimal myocardial blush or contrast density. * MBG 2 = Moderate myocardial blush or contrast density but less than that obtained during angiography of a contralateral or ipsi-lateral non-infarct-related coronary artery. * MBG 3 = Normal myocardial blush or contrast density, comparable with that obtained during angiography of a contralateral or ipsilateral non-infarct-related coronary artery Coronary no-reflow (CNR) is diagnosed immediately after PCI when post-procedural angiographic MBG is 0 or 1
1 secondary outcome
MACE
Time frame: 1 year up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
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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.
Mostafa Abdallah Khalifa, Master cardiology contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Adrenaline in people with ST Segment Elevation Myocardial Infarction (STEMI) and No Reflow Phenomenon, run by Ain Shams 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 2 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: looking for participants now, as of the sponsor's last update on 11 Mar 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mostafa Abdallah Khalifa, Master cardiology (+201012988025, mostafaabdallahkhalifa@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
No-relow (time frame: 1 year up to 2 years). The study lists 2 primary outcomes in all. 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 11 Mar 2025.