Adrenaline for the Treatment of No-Reflow in Normotensive Patients

NCT04699110 | Completed Phase 4 DMC

• 1 other identifier: ERC-76/2020
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome; No-Reflow Phenomenon; Normotensive

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• The major adverse cardiovascular events

  During hospital stay and at 30-day follow-up

Study Arms (2)

Treatment group

EXPERIMENTAL

Patients receiving intracoronary adrenaline

Drug: Adrenaline

Control group

ACTIVE COMPARATOR

Patients receiving intracoronary adenosine

Drug: Adenosine

Interventions

Adrenaline DRUG

Treatment group will receive adrenaline (100 to 400 mcg) for the treatment of No-reflow

Treatment group

Adenosine DRUG

Control group will receive adenosine (100 to 400 mcg)

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients with acute coronary syndrome who developed No-reflow during PCI.
• Patients with systolic blood pressure of \> 100 mmHg.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Cardiovascular Diseases, Pakistan: lead

Study Sites (1)

National Institute of Cardiovascular Diseases

Karachi, Sindh, Pakistan

Location

Related Publications (1)

• Khan KA, Qamar N, Saghir T, Sial JA, Kumar D, Kumar R, Qayyum D, Yasin U, Jalbani J, Karim M. Comparison of Intracoronary Epinephrine and Adenosine for No-Reflow in Normotensive Patients With Acute Coronary Syndrome (COAR Trial). Circ Cardiovasc Interv. 2022 Feb;15(2):e011408. doi: 10.1161/CIRCINTERVENTIONS.121.011408. Epub 2022 Jan 10.

  PMID: 35000456 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome; No-Reflow Phenomenon

Interventions

Epinephrine; Adenosine

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Cardiology

Study Record Dates

• First Submitted: January 5, 2021
• First Posted: January 7, 2021
• Study Start: January 1, 2021
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: May 21, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)