Intramyocardial Haemorrhage in Patients With Primary STEMI

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

Detailed Description
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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.

Official Title
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Clinical Trial Appreciating Intramyocardial Haemorrhage in Patients With Primary STEMI and Different Reperfusion Strategies (Pharmaco Invasive Strategy and Primary PCI)

Conditions
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STEMI, Myocardial Infarction, Myocardial Necrosis, Myocardial Injury

Intervention / Treatment
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* Drug: Pharmaco-invasive strategy
* Procedure: Primary PCI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years at time of randomization (18 years and older); Acute myocardial infarction; Reperfusion of the infarct-related coronary artery in terms within 12 h of symptom onset; Written the informed consent to participate in research; Exclusion Criteria: Inability to obtain informed consent; Patients previously undergone endovascular / surgical revascularization of coronary artery; Severe comorbidity; History of myocardial infarction; History of intracranial haemorrhage; Pulmonary edema, cardiogenic shock; Creatinine clearance <30 mL/min or dialysis; Unable to undergo or contra-indications for MRI; Allergy for contrast agent; Indication or use of oral anticoagulant therapy; Major bleedind; Atrio-ventricular block II and III degree; Active gastroduodenal ulcer; Aortic dissection; Acute psychotic disorders

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pharmaco-invasive strategy<br>Fibrinolytic therapy (Streptokinase, Alteplasa, Tenecteplasa in standard dose) is conducted within 12 h of symptom onset in the pre-hospital setting if primary PCI cannot be performed within 120 min from STEMI diagnosis. Then PCI is performed to all of patients. | Drug: Pharmaco-invasive strategy<br>* 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.<br>* Other names: Streptokinase;|
| Active Comparator: Primary PCI<br>Primary percutaneous coronary intervention (PCI) in patients with primary STEMI | Procedure: Primary PCI<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intramyocardial haemorrhage in primary STEMI measure | Intramyocardial haemorrhage (%) in patients with primary STEMI as assessed by cardiac magnetic resonance imaging 2 days after reperfusion | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular ejection fraction (LVEF) recovery measure | Left ventricular ejection fraction (LVEF) (%) recovery measured with echocardiography 7 days and 3 months after reperfusion strategies | 3 months (with intermediate measurement at day 7 after reperfusion) | 
| Global Longitudinal Strain | Global Longitudinal Strain (%) measured with echocardiography 7 days and 3 months after reperfusion strategies | 3 months (with intermediate measurement at day 7 after reperfusion) | 
| Recurrent myocardial infarction measure | Incidence of recurrent myocardial infarction (%) 3 months after STEMI | 3 months | 
| Heart failure incidence measure | Incidence of heart failure (%) 3 months after STEMI | 3 months | 
| Stroke incidence measure | Incidence of stroke (%) 3 months after STEMI | 3 months | 
| Mortality measure | Mortality rate (%) 3 months after STEMI | 3 months | 
| Major bleeding incidence measure | Incidence of major bleeding (%) 3 months after STEMI | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intramyocardial haemorrhage, Myocardial Infarction, ST Elevation Myocardial Infarction, Primary Percutaneous Coronary Intervention, Pharmaco invasive strategy, Fibrinolytic therapy, Global longitudinal strain, Myocardial Necrosis, Coronary Artery Disease