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Clinical Trial Summary

The purpose of the study is to assess the frequency and intensity of intramyocardial haemorrhage in patients with primary STEMI and different reperfusion strategies.


Clinical Trial Description

The study non-randomized, opened, controlled. In half of patients despite on carried in-time reperfusion therapy intramyocardial haemorrhage determined after a long-term period of severe ischemia. Earlier, definition of intramyocardial haemorrhage was possible only by autopsy. Nowaday, cardiac contrast MRI is the best diagnostic method, which allows to assess the regional and global function of the LV, structural changes in myocardial tissue and also in T2 mode it became assessable to reveal intramyocardial haemorrhage.

Taking into account the results of previous researches, it can be concluded that the intramyocardial haemorrhage was determined in half of patients with primary PCI [1]. An influence of fibrinolytic therapy to the intramyocardial haemorrhage was conducted in small group of patients in one trial, and therefore further data will be actual and useful [2].

It is planned to study 60 patients with primary STEMI using standard therapy. The patients will be divided into 2 groups. Patients of the 1st group will be treated by pharmaco-invasive strategy. The 2nd group will be treated by primary PCI. Patients in all groups after reperfusion strategies will be conducted cardiac contrast MRI for detection intramyocardial haemorrhage within 2 days onset. At day 7 and through 3 months, the clinical condition of the patients will be assessed and cardiac ultrasound will be performed for the evaluation of myocardial contractile function and 2D global longitudinal strain. Also, the incidence rate of secondary endpoints will be evaluated. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03677466
Study type Interventional
Source Tomsk National Research Medical Center of the Russian Academy of Sciences
Contact
Status Completed
Phase N/A
Start date January 25, 2018
Completion date March 20, 2019

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