Intramyocardial Haemorrhage in Patients With Primary STEMI (HaemInCor)

Tomsk National Research Medical Center of the Russian Academy of Sciences

Status: Completed

Conditions: Myocardial Necrosis; Myocardial Infarction; STEMI; Myocardial Injury

Treatments: Procedure: Primary PCI; Drug: Pharmaco-invasive strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT03677466

HaemInCor

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Pharmaco-invasive strategy

Experimental group

Description:

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.

Treatment:

Drug: Pharmaco-invasive strategy

Primary PCI

Active Comparator group

Description:

Primary percutaneous coronary intervention (PCI) in patients with primary STEMI

Treatment:

Procedure: Primary PCI