NCT03677466

Intramyocardial Haemorrhage in Patients With Primary STEMI

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myocardial Infarction
• STEMI
• Myocardial Necrosis
• Myocardial Injury

Interventions

Type	Name	Description
DRUG	Pharmaco-invasive strategy	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.
PROCEDURE	Primary PCI	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.

Timeline

• Start date: 2018-01-25
• Primary completion: 2018-10-30
• Completion: 2019-03-20
• First posted: 2018-09-19
• Last updated: 2019-04-05

Locations

1 site across 1 country: Russia