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Clinical Trials/NCT04699110
NCT04699110CompletedPhase 4

Efficacy of Intracoronary Adrenaline and Its Comparison With Intracoronary Adenosine in the Treatment of No-Reflow in Normotensive Patients With Acute Coronary Syndrome

National Institute of Cardiovascular Diseases, Pakistan1 site in 1 country201 target enrollmentStarted: January 1, 2021Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
201
Locations
1
Primary Endpoint
Improvement in Thrombolysis in Myocardial Infarction (TIMI) flow grade

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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

Arms & Interventions

Control group

Active Comparator

Patients receiving intracoronary adenosine

Intervention: Adenosine (Drug)

Treatment group

Experimental

Patients receiving intracoronary adrenaline

Intervention: Adrenaline (Drug)

Outcomes

Primary Outcomes

Improvement in Thrombolysis in Myocardial Infarction (TIMI) flow grade

Time Frame: Immediately after administration of drug

Reduction in TIMI frame count

Time Frame: Immediately after administration of drug

Secondary Outcomes

  • The major adverse cardiovascular events(During hospital stay and at 30-day follow-up)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Kamran Ahmed Khan

Assistant Professor of Cardiology

National Institute of Cardiovascular Diseases, Pakistan

Study Sites (1)

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