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Completed

NCT Number: NCT04699110

Adrenaline for the Treatment of No-Reflow in Normotensive Patients

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.

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Ischemia Myocardial Ischemia No-Reflow Phenomenon Normotensive Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

National Institute of Cardiovascular Diseases

Karachi, Sindh, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adrenaline

Drug

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

Adenosine

Drug

Control group will receive adenosine (100 to 400 mcg)

Primary outcomes

  1. Improvement in Thrombolysis in Myocardial Infarction (TIMI) flow grade

    Time frame: Immediately after administration of drug

  2. Reduction in TIMI frame count

    Time frame: Immediately after administration of drug

Secondary outcomes

  1. The major adverse cardiovascular events

    Time frame: During hospital stay and at 30-day follow-up

Sponsors and collaborators

Lead sponsor

National Institute of Cardiovascular Diseases, Pakistan

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 7, 2021
Registry last updated
May 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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