Cardiology Research Institute
Tomsk, 634012, Russia
NCT Number: NCT03677466
The purpose of the study is to assess the frequency and intensity of intramyocardial haemorrhage in patients with primary STEMI and different reperfusion strategies.
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All sexes
Interventional
Not applicable
Tomsk, 634012, Russia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patient with primary STEMI will received standard doses of fibrinolytics with following PCI.
After reperfusion strategies will be conducted cardiovascular magnetic resonance (CMR) imaging with contrast (Gadovist) in regime inversion recovery time, regime T-2 weighted images, T1-weighted images. and Global Longitudinal Strain measured with echocardiography.
Other names: Metalyse, Actilyse, Tenecteplase, Alteplase, Streptokinase
After primary PCI patients will be conducted cardiovascular magnetic resonance (CMR) imaging with contrast (Gadovist) in regime inversion recovery time, regime T-2 weighted images, T1-weighted images and Global Longitudinal Strain measured with echocardiography.
Time frame: 2 days
Intramyocardial haemorrhage (%) in patients with primary STEMI as assessed by cardiac magnetic resonance imaging 2 days after reperfusion
Time frame: 3 months (with intermediate measurement at day 7 after reperfusion)
Left ventricular ejection fraction (LVEF) (%) recovery measured with echocardiography 7 days and 3 months after reperfusion strategies
Time frame: 3 months (with intermediate measurement at day 7 after reperfusion)
Global Longitudinal Strain (%) measured with echocardiography 7 days and 3 months after reperfusion strategies
Time frame: 3 months
Incidence of recurrent myocardial infarction (%) 3 months after STEMI
Time frame: 3 months
Incidence of heart failure (%) 3 months after STEMI
Time frame: 3 months
Incidence of stroke (%) 3 months after STEMI
Time frame: 3 months
Mortality rate (%) 3 months after STEMI
Time frame: 3 months
Incidence of major bleeding (%) 3 months after STEMI
Tomsk National Research Medical Center of the Russian Academy of Sciences
Other
Clinical Trial Appreciating Intramyocardial Haemorrhage in Patients With Primary STEMI and Different Reperfusion Strategies (Pharmaco Invasive Strategy and Primary PCI)
Acronym: HaemInCor
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