ClinicalTrials.gg
RecruitingNCT06847568Updated Mar 11, 2025

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 interventional study of Adrenaline in ST Segment Elevation Myocardial Infarction (STEMI) and No Reflow Phenomenon, sponsored by Ain Shams University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-11.

Sponsored by Ain Shams University · Phase 3, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Apr 2026, 6 months ago, but the record still lists the study as recruiting.
  • Registered 10 months after the study started (first participant enrolled Apr 2024, registered Feb 2025).
  • Started Apr 2024; still recruiting 2 years 7 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
1,000
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 30 studies in ST Elevation Myocardial Infarction with a site in Egypt — 11 open to participants now, 11 under way, 3 of them phase 3. ST Elevation Myocardial Infarction · Egypt.

Planned enrollment
2nd of 12
1,000 · median 106
Started
2024
with 2 others
Phase 3
5 of 30
3 open now
Primary completion
2026-04
later than 5 of 10 live
Registered
23rd of 30
by date
Lead sponsor
2 of 30
Ain Shams University

Among the 30 studies in ST Elevation Myocardial Infarction with a site in Egypt, this one is the 2nd largest by planned enrollment of the 12 interventional ones that give a count, is one of 3 that started in 2024, is one of 5 in phase 3, reaches primary completion later than 5 of the 10 other live ones, and was the 23rd registered.

ST Elevation Myocardial Infarction

850 studies on the registry are indexed under ST Elevation Myocardial Infarction; 197 are open to participants now.

Browse ST Elevation Myocardial Infarction studies →

Open to participants now

11 of the 30 studies in ST Elevation Myocardial Infarction with a site in Egypt are open now. Recruiting first, the newest first:

5 more — sign in →

All 11 open studies →

A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →

Who these studies take

Of the 122 ST Elevation Myocardial Infarction studies recruiting now, 76 (62%) set no upper age limit and 20 (16%) stop at 75 or younger; 10 take children under 18; 9 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 30 studies in ST Elevation Myocardial Infarction with a site in Egypt, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • ST Segment Elevation Myocardial Infarction (STEMI)
  • No Reflow Phenomenon

Keywords

  • STEMI
  • No-reflow
  • Adrenaline
  • Prophylaxis
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients who are 18 years or older
  2. Patients presenting with acute coronary syndrome with 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.

Exclusion criteria

Exclusion Criteria:

  1. Age \< 18 years
  2. Pregnant females.
  3. Patients refused to give consent.
  4. Patients who had normal coronary angiography.
  5. Patients who had CTO lesions.
  6. Patients who have SCAD.
  7. Patients who developed dissection or mechanical complication during the procedure.
  8. Patients presenting with cardiogenic shock.
  9. Cardiomyopathies
  10. to epinephrine as HTN with SBP >180 mmHg or DBP>110 mmHg, arrhythmia (Atrial fibrillation with rapid ventricular rate, ventricular tachycardia, or ventricular fibrillation) prior to PCI, known allergy to epinephrine.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
1,000 participants (estimated)

Study arms

  • Active comparator
    Study (Adrenaline)

    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.

    Drug: Adrenaline

  • No intervention
    Control

    This group will receive the standards of care , all guidelines-directed recommendations of intervention in STEMI patients.

Interventions

  • 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.

    Also known as: Epinephrine

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 1 year up to 2 years

  2. 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

    Time frame: 1 year up to 2 years

Secondary outcomes

  1. MACE

    Secondary end points will be major adverse cardiac events.

    Time frame: 1 year up to 2 years

07

Study locations

1 of 1 sites recruiting
  • Faculty of medicine Ain Shams Univesity
    Cairo, Egypt
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2024 (actual). Primary completion is estimated for Apr 2026, 24 months after the start.

Of 38 phase 3 interventional studies under ST Elevation Myocardial Infarction, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 58. This study's planned 24 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 16, 2025
First posted
Feb 26, 2025
StartActual
Apr 1, 2024
Primary completionEst.
Apr 30, 2026
CompletionEst.
Apr 30, 2026
Last update
Mar 11, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06847568
Responsible party
Mostafa AbdAllah Khalifa (Assistant lecturer of cardiology, Ain Shams University) — Principal investigator
First posted
Feb 26, 2025
Start date
Apr 1, 2024
Primary completion
Apr 30, 2026 (estimated)
Completion
Apr 30, 2026 (estimated)
Last update
Mar 11, 2025

Study contacts

Mostafa Abdallah Khalifa, Master cardiology
Contact
mostafaabdallahkhalifa@med.asu.edu.eg
+201012988025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Epinephrine

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