Intramyocardial Haemorrhage in Patients With Primary STEMI

Not Applicable

Completed

• Conditions: STEMI; Myocardial Necrosis; Myocardial Infarction; Myocardial Injury
• Interventions: Procedure: Primary PCI; Drug: Pharmaco-invasive strategy

• Registration Number: NCT03677466
• Lead Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences

Brief 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.

Detailed 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 Timeline

• Study Start: 2018-01-25
• Study First Submitted: 2018-09-17
• Study First Submitted QC: 2018-09-17
• Study First Posted: 2018-09-19
• Primary Completion: 2018-10-30
• Status Verified: 2019-03
• Study Completion: 2019-03-20
• Last Update Submitted: 2019-04-04
• Last Update Posted: 2019-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Primary PCI	Primary PCI	Primary percutaneous coronary intervention (PCI) in patients with primary STEMI
Pharmaco-invasive strategy	Pharmaco-invasive strategy	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.

Primary Outcome Measures

Name	Time	Method
Intramyocardial haemorrhage in primary STEMI measure	2 days	Intramyocardial haemorrhage (%) in patients with primary STEMI as assessed by cardiac magnetic resonance imaging 2 days after reperfusion

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cardiology Research Institute; 🇷🇺 Tomsk, Russian Federation