Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04573751 |
| Other study ID # |
EPIVER |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 30, 2020 |
| Est. completion date |
January 31, 2024 |
Study information
| Verified date |
April 2024 |
| Source |
Tomsk National Research Medical Center of the Russian Academy of Sciences |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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)
Description:
Primary percutaneous coronary intervention (PPCI) is the preferred reperfusion strategy for
treating acute ST-segment elevation myocardial infarction (STEMI). The main goals are to
restore epicardial infarct-related artery patency and to achieve microvascular reperfusion as
early as possible. No-reflow is the term used to describe inadequate myocardial perfusion of
a given coronary segment without angiographic evidence of persistent mechanical obstruction
of epicardial vessels and it refers to the high resistance of microvascular blood flow
encountered during opening of the infarct-related coronary artery. Despite optimal
evidence-based PPCI, myocardial no-reflow 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.
According to clinical guidelines, nitrates, adenosine, platelet IIb / IIIa receptor
inhibitors and thrombus extraction can be used to prevent and treat this complication.These
methods have demonstrated the ability to improve coronary blood flow in experiment and small
clinical trials, however, limiting the zone of myocardial necrosis and improving disease
outcomes have not been achieved.
The search for new methods of influencing the pathogenetic links of this complication is
urgent. One of the main potentially reversible factors in the pathogenesis of the no-reflow
phenomenon, along with microvascular obstruction, is microvascular arteriolar spasm. Thus,
this problem of emergency cardiology remains relevant and requires further research, new
methods of prevention and treatment.
Aside from exerting beta-1 agonist properties at higher doses and increasing the inotropic
and chronotropic stimulation of the myocardium, epinephrine may, at lower doses, exert potent
beta receptor agonist properties that mediate coronary vasodilatation. Another drug with a
pronounced coronary vasodilation effect is verapamil.
Based on the pharmacodynamic effects of epinephrine and verapamil, it is expected to increase
the vasodilating effect when they are used together, due to the additive type of synergistic
interaction, which will improve coronary microcirculation after PCI in patients with acute
myocardial infarction and refractory no-reflow phenomenon.
Currently, in clinical practice, there is a possibility of very sensitive diagnosis of
microvascular obstruction (MVO) using magnetic resonance imaging (MRI), as well as the area
of the coronary reserve according to dynamic perfusion scintigraphy of the myocardium. It is
advisable to evaluate the effectiveness of treatment of the no-reflow phenomenon using these
methods.
The trial aims to estimate the efficacy and safety of the administration of intracoronary
epinephrine, verapamil, as well as their combination versus to standard treatment in patients
with STEMI and refractory coronary no-reflow despite conventional treatments during PPCI.
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