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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:

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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
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