The EPIVER Randomized Controlled Trial

NCT04573751 | Completed

• 1 other identifier: EPIVER
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

The trial aims to estimate the efficacy and safety of the intracoronary administration of adrenalin, verapamil, as well as their combination compared to standard treatment in patients with STEMI and refractory coronary no-reflow despite conventional treatment during percutaneous coronary intervention (PPCI)

Conditions

ST Elevation Myocardial Infarction; Percutaneous Coronary Intervention; No-Reflow Phenomenon

Keywords

Primary PCI; No-reflow; Intracoronary epinephrine

Outcome Measures

Primary Outcomes (2)

• Mortality

  Mortality rate (percent)

  month 1

• New onset or worsening acute heart failure

  The rate (percent) of patients experiencing new onset or worsening acute heart failure. Congestion characterized by dyspnea, edema, rales, jugular venous distention and need to increase diuretic doses is a hallmark of acute heart failure prompting hospitalization

  month 1

Secondary Outcomes (12)

• Thrombolysis in myocardial infarction (TIMI) 3

  hour 1

• Change in systolic/diastolic blood pressure

  minute 3

• ST segment resolution

  hour 72

• Troponin I release

  hour 72

• LV EF

  day 10

Study Arms (4)

Standard therapy

SHAM COMPARATOR

No intracoronary epinephrine and verapamil

Drug: Standard therapy

Epinephrine

ACTIVE COMPARATOR

Intracoronary bolus epinephrine injection requires two ampoules each of 1:1,000 epinephrine (1 μg/mL) diluted into 100 mL of normal saline solution (to 20 μg/mL epinephrine solution); therefore, a 5-mL syringe contains 100 μg of epinephrine. Intracoronary epinephrine will be administered at a dose of 100 μg and at a lower dose of 80 μg in patients with blood pressure \>160 mmHg

Drug: Epinephrine

Verapamil

ACTIVE COMPARATOR

Intracoronary verapamil is administered at a dose of 0.5 mg.

Drug: Verapamil

Epinephrine + verapamil

ACTIVE COMPARATOR

Intracoronary administration of epinephrine at a dose of 80-100 μg and verapamil at a dose of 0.5 mg.

Drug: Epinephrine + verapamil

Interventions

Standard therapy DRUG

Standard therapy as follows: adenosine, nitroglycerine, thrombus aspiration/extraction, and platelet IIb/IIIa receptor inhibitors.

Also known as: Control

Standard therapy

Epinephrine DRUG

Standard therapy plus epinephrine as follows: epinephrine, adenosine, nitroglycerine, thrombus aspiration/extraction, and platelet IIb/IIIa receptor inhibitors.

Also known as: Epi

Epinephrine

Verapamil DRUG

Standard therapy plus verapamil as follows: verapamil, adenosine, nitroglycerine, thrombus aspiration/extraction, and platelet IIb/IIIa receptor inhibitors.

Also known as: Ver

Verapamil

Epinephrine + verapamil DRUG

Standard therapy plus epinephrine + verapamil as follows: epinephrine, verapamil, adenosine, nitroglycerine, thrombus aspiration/extraction, and platelet IIb/IIIa receptor inhibitors.

Also known as: Epi+Ver

Epinephrine + verapamil

Eligibility Criteria

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

You may qualify if:

• patients with ST-elevation myocardial infarction
• Infarct-related artery TIMI flow grade 0-2 during the interventional procedure after the initial opening of the vessel.
• Written the informed consent to participate in research

You may not qualify if:

• Unable to undergo or contra-indications for MRI or SPECT

Sponsors & Collaborators

• Tomsk National Research Medical Center of the Russian Academy of Sciences: lead

Study Sites (1)

Cardiology Research Institute, Tomsk NRMC

Tomsk, Tomsk Oblast, Russia

Location

Related Publications (1)

• Dil S, Ryabov V, Maslov L, Mochula O, Mochula A, Kercheva M, Zavadovsky K, Vyshlov E. Assessing coronary microvascular dysfunction in refractory no-reflow: Insights from dynamic myocardial perfusion scintigraphy and cardiac MRI. Microvasc Res. 2025 Nov;162:104862. doi: 10.1016/j.mvr.2025.104862. Epub 2025 Aug 20.

  PMID: 40846132 DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; No-Reflow Phenomenon

Interventions

Standard of Care; Epinephrine; Verapamil; Evoked Potentials, Visual

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenethylamines; Ethylamines; Evoked Potentials; Cortical Excitability; Electrophysiological Phenomena; Physiological Phenomena; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Ocular Physiological Phenomena

Study Officials

• Vyacheslav V Ryabov, MD, PhD

  Cardiology Research Institute, Tomsk NRMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: October 5, 2020
• Study Start: December 30, 2020
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2024
• Last Updated: April 29, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)