Adrenaline for the Treatment of No-Reflow in Normotensive Patients

• Sponsor: National Institute of Cardiovascular Diseases, Karachi (Other)
• Overall Status: Completed
• CT.gov ID: NCT04699110
• Collaborator: (none)
• Enrollment: 201
• Location: 1
• Arms: 2
• Actual Duration (Months): 3.9
• Patients Per Site Per Month: 51.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome; No-Reflow Phenomenon; Normotensive	Drug: Adrenaline; Drug: Adenosine	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 201 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jan 1, 2021
• Actual Primary Completion Date: Apr 30, 2021
• Actual Study Completion Date: Apr 30, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Improvement in Thrombolysis in Myocardial Infarction (TIMI) flow grade [Immediately after administration of drug]

2. Reduction in TIMI frame count [Immediately after administration of drug]

Secondary Outcome Measures

1. The major adverse cardiovascular events [During hospital stay and at 30-day follow-up]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Institute of Cardiovascular Diseases	Karachi	Sindh	Pakistan

Sponsors and Collaborators

• National Institute of Cardiovascular Diseases, Karachi

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kamran Ahmed Khan, Assistant Professor of Cardiology, National Institute of Cardiovascular Diseases, Karachi
• ClinicalTrials.gov Identifier: NCT04699110
• Other Study ID Numbers: ERC-76/2020
• First Posted: Jan 7, 2021
• Last Update Posted: May 21, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Acute Coronary Syndrome; Syndrome; No-Reflow Phenomenon; Adenosine; Epinephrine; Racepinephrine; Epinephryl borate

Study Results

No Results Posted as of May 21, 2021