Clinical Trials Logo

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.


Recruitment information / eligibility

Status Completed
Enrollment 104
Est. completion date January 31, 2024
Est. primary completion date January 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Unable to undergo or contra-indications for MRI or SPECT

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Russian Federation Cardiology Research Institute, Tomsk NRMC Tomsk Tomsk Region

Sponsors (1)

Lead Sponsor Collaborator
Tomsk National Research Medical Center of the Russian Academy of Sciences

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mortality Mortality rate (percent) month 1
Primary 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 Thrombolysis in myocardial infarction (TIMI) 3 The rate of patients (percent) who achieved TIMI 3 coronary blood flow after percutaneous coronary intervention hour 1
Secondary Change in systolic/diastolic blood pressure Change in systolic/diastolic blood pressure values (mmHg) before and after intracoronary verapamil/epinephrine minute 3
Secondary ST segment resolution Degree of ST segment resolution on ECG (mm) hour 72
Secondary Troponin I release Concentration of troponin I (ng/mL) hour 72
Secondary LV EF Left ventricular ejection fraction (LV EF) (percent) day 10
Secondary Myocardial injury Total volume (mL) of microvascular obstruction, myocardial necrosis, edema, and hemorrhagic impregnation according to MRI data day 2
Secondary SPECT-based coronary reserve Coronary reserve will be measured by cardiac single photon emission computed tomography (SPECT) with technetium-99m-labeled methoxy-isobutyl isonitrile (99m??MIBI) at rest and during pharmacological stress-test (counts) day 7
Secondary Change in heart rate values Change in heart rate values (beat per minute) before and after intracoronary verapamil/epinephrine minute 3
Secondary LV EDV Left ventricular end-diastolic volume (LV EDV) (mL) 10 days
Secondary LV ESV Left ventricular end-systolic volume (LV ESV) (mL) day 10
Secondary LV WMSI Left ventricular wall motion score index (LV WMSI) (conventional units) day 10
Secondary Arrhythmias Frequency of arrhythmias (atrial fibrillation, atrial flutter?, supraventricular tachycardia, premature ventricular contractions, ventricular tachycardia, conduction disorders and other heart rhythm disorders) after intracoronary administration verapamil and/or epinephrine minute 5
See also
  Status Clinical Trial Phase
Terminated NCT03959072 - Cardiac Cath Lab Staff Radiation Exposure
Not yet recruiting NCT05669222 - The FAVOR V AMI Trial N/A
Recruiting NCT04566497 - Assessment of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up. N/A
Recruiting NCT05240781 - Zotarolimus vs Sirolimus Eluting Stent in High Bleeding Risk N/A
Recruiting NCT03378934 - Anti-platelet Effect of Berberine in Patients After Percutaneous Coronary Intervention Phase 4
Not yet recruiting NCT06025071 - Residual Inflammatory Risk-Guided colcHicine in Elderly Trial Phase 4
Withdrawn NCT04043091 - Coronary Angiography in Critically Ill Patients With Type II Myocardial Infarction N/A
Completed NCT02837744 - Studying Hemostatic Effect of Axiostat® Dressing on Radial Access After Percutaneous Procedure
Completed NCT03085823 - The All-comers Sirolimus-coated Balloon European Registry
Completed NCT02044146 - A Pharmacodynamic Study of a Personalized Strategy for P2Y12 Inhibition Versus Ticagrelor in Reducing Ischemic and Bleeding Risk Phase 2/Phase 3
Completed NCT03131271 - Effect of Ice Bag Application to Femoral Region on Pain in Patients Undergoing Percutaneous Coronary Intervention N/A
Completed NCT01156571 - A Clinical Trial Comparing Cangrelor to Clopidogrel Standard Therapy in Subjects Who Require Percutaneous Coronary Intervention (PCI) (CHAMPION PHOENIX) Phase 3
Completed NCT01135667 - Prasugrel Versus Double Dose Clopidogrel to Treat Clopidogrel Low-responsiveness After PCI Phase 4
Unknown status NCT00751491 - Clopidogrel Versus Adenosin in Non Urgent Percutaneous Coronary Intervention (PCI) Phase 3
Completed NCT00725868 - Blood Endothelium Biomarkers to Predict Major Adverse Cardiovascular Events After Percutaneous Coronary Intervention N/A
Completed NCT03708588 - Chewed Versus Integral Pill of Ticagrelor Phase 4
Completed NCT04163393 - R-One Efficiency For PCI Evolution With Robotic Assistance N/A
Recruiting NCT05554588 - Intrathrombus Thrombolysis Versus Aspiration Thrombectomy During Primary PCI N/A
Recruiting NCT06080919 - Plaque Modification And Impact On Microcirculatory Territory After Drug-Coated Balloon Percutaneous Coronary Intervention (PLAMI). N/A
Recruiting NCT05353140 - LAAO Versus NOAC in Patients With AF and PCI N/A