Adrenaline for the Treatment of No-Reflow in Normotensive Patients

Phase 4

Completed

• Conditions: No-Reflow Phenomenon; Acute Coronary Syndrome; Normotensive
• Interventions: Drug: Adrenaline; Drug: Adenosine

• Registration Number: NCT04699110
• Lead Sponsor: National Institute of Cardiovascular Diseases, Pakistan

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2021-01-05
• Study First Submitted QC: 2021-01-05
• Study First Posted: 2021-01-07
• Primary Completion: 2021-04-30
• Study Completion: 2021-04-30
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-20
• Last Update Posted: 2021-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group	Adrenaline	Patients receiving intracoronary adrenaline
Control group	Adenosine	Patients receiving intracoronary adenosine

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
The major adverse cardiovascular events	During hospital stay and at 30-day follow-up

Trial Locations

Locations (1)

National Institute of Cardiovascular Diseases; 🇵🇰 Karachi, Sindh, Pakistan