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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control | No Intervention | This group will receive the standards of care , all guidelines-directed recommendations of intervention in STEMI patients. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adrenaline | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
Coronary no-reflow (CNR) is diagnosed immediately after PCI when post-procedural angiographic TIMI flow is < 3 | 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:
Coronary no-reflow (CNR) is diagnosed immediately after PCI when post-procedural angiographic MBG is 0 or 1 | 1 year up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| MACE | Secondary end points will be major adverse cardiac events. | 1 year up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mostafa Abdallah Khalifa, Master cardiology | Contact | +201012988025 | mostafaabdallahkhalifa@med.asu.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of medicine Ain Shams Univesity | Recruiting | Cairo | Egypt |
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|
|
| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| D054318 | No-Reflow Phenomenon |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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| ID | Term |
|---|---|
| D004837 | Epinephrine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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