Adrenaline for the Treatment of No-Reflow in Normotensive Patients

Acute Coronary Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04699110
• Other study ID #: ERC-76/2020
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2021
• Est. completion date: April 30, 2021

Study information

• Verified date: May 2021
• Source: National Institute of Cardiovascular Diseases, Karachi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: April 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• No-Reflow Phenomenon
• Normotensive
• Syndrome

Intervention

Drug:
• Adrenaline
Treatment group will receive adrenaline (100 to 400 mcg) for the treatment of No-reflow
• Adenosine
Control group will receive adenosine (100 to 400 mcg)

Locations

Country	Name	City	State
Pakistan	National Institute of Cardiovascular Diseases	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Cardiovascular Diseases, Karachi

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in Thrombolysis in Myocardial Infarction (TIMI) flow grade		Immediately after administration of drug
Primary	Reduction in TIMI frame count		Immediately after administration of drug
Secondary	The major adverse cardiovascular events		During hospital stay and at 30-day follow-up