Adrenaline for the Treatment of No-Reflow in Normotensive Patients

Study Overview
=================
Brief Summary
-----------------
No-reflow is defined as the lack of myocardial perfusion despite opening of the epicardial coronary vessels in the setting of percutaneous coronary intervention (PCI). It has been demonstrated that either impaired flow or the absence of flow is associated with an increased rate of mortality. Among available treatment options, intracoronary adenosine is widely used in clinical practice, moreover, adrenaline is a safe alternative for the cases where use of adenosine is limited due to presence of hypotension or bradycardia. Nonetheless, evidence from retrospective and observational studies suggest that intracoronary adrenaline is well tolerated and may exert encouraging effects in prompt recovery of flow in these patients. However, very limited data are available on efficacy of intracoronary (IC) adrenaline in normotensive patients. Therefore, this study is planned to study the hypothesis that; intracoronary adrenaline is safe and has significantly higher efficacy as compared to adenosine for the treatment of no-reflow in normotensive patients with acute coronary syndrome.

Official Title
-----------------
Efficacy of Intracoronary Adrenaline and Its Comparison With Intracoronary Adenosine in the Treatment of No-Reflow in Normotensive Patients With Acute Coronary Syndrome

Conditions
-----------------
Acute Coronary Syndrome, No-Reflow Phenomenon, Normotensive

Intervention / Treatment
-----------------
* Drug: Adrenaline
* Drug: Adenosine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with acute coronary syndrome who developed No-reflow during PCI. Patients with systolic blood pressure of > 100 mmHg. Exclusion Criteria: Hypotensive patients Patients with Valvular or congenital heart disease. Patients with Atypical chest pain Patients with Cardiomyopathy Patients with Pericarditis Patients with Myocarditis Patients refused to give consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>Patients receiving intracoronary adrenaline | Drug: Adrenaline<br>* Treatment group will receive adrenaline (100 to 400 mcg) for the treatment of No-reflow<br>|
| Active Comparator: Control group<br>Patients receiving intracoronary adenosine | Drug: Adenosine<br>* Control group will receive adenosine (100 to 400 mcg)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Thrombolysis in Myocardial Infarction (TIMI) flow grade |  | Immediately after administration of drug | 
| Reduction in TIMI frame count |  | Immediately after administration of drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The major adverse cardiovascular events |  | During hospital stay and at 30-day follow-up |