Adrenaline for the Treatment of No-Reflow in Normotensive Patients

National Institute of Cardiovascular Diseases, Pakistan

Status and phase: Completed; Phase 4

Conditions: Normotensive; No-Reflow Phenomenon; Acute Coronary Syndrome

Treatments: Drug: Adrenaline; Drug: Adenosine

Study type: Interventional

Funder types: Other

Identifiers

NCT04699110

ERC-76/2020

Details and patient eligibility

About

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.

Enrollment: 201 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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201 participants in 2 patient groups

Treatment group

Experimental group

Description:

Patients receiving intracoronary adrenaline

Treatment:

Drug: Adrenaline

Control group

Active Comparator group

Description:

Patients receiving intracoronary adenosine

Treatment:

Drug: Adenosine