Jornal de Ensaios Clínicos
Acesso livre
ISSN: 2167-0870
ISSN: 2167-0870
Stanislav V Dil*, Vyacheslav V Ryabov, Evgeny V Vyshlov
Background: Refractory no-reflow syndrome can still occur, negating many of the benefits of restoring culprit vessel patency, and is associated with a worse in-hospital and long-term prognosis. Epinephrine may at lower doses exert potent beta receptor agonist properties that mediate coronary vasodilatation. The trial aims to estimate the efficacy and safety of the administration of intracoronary adrenalin, verapamil, as well as their combination versus standard treatment in patients with STEMI and refractory coronary no-reflow.
Methods/Design: Consecutive patients with STEMI and refractory no-reflow syndrome will be randomized into 4 groups: Standard therapy only, intracoronary administration of epinephrine, verapamil, epinephrine+verapamil. All patients will undergo an assessment of epicardial blood flow using TIMI score, peak troponin level, ST segment dynamics, echocardiography, MRI, dynamic SPECT.
Discussion: Based on the pharmacodynamic effects of epinephrine and verapamil, their combination is expected to have a more potent vasodilating effect. The study protocol follows the Declaration of Helsinki and has been approved by the ethics committee of the authors’ institution on October 14, 2020. The study complies with the national standard of good clinical practice (RF GOST P52379-2005 form April 1, 2006) and with the international guidelines for good clinical practice.
Conclusion: Investigators or investigator-authorized officers will be responsible for explaining the objective, content, study procedures, benefits, and risks of participating in the clinical trial to each patient or the patient's legal representative. Written informed consent will be obtained from all patients before the start of the trial.