Intramyocardial Haemorrhage in Patients With Primary STEMI (HaemInCor)
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|ClinicalTrials.gov Identifier: NCT03677466|
Recruitment Status : Completed
First Posted : September 19, 2018
Last Update Posted : April 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Myocardial Infarction STEMI Myocardial Necrosis Myocardial Injury||Drug: Pharmaco-invasive strategy Procedure: Primary PCI||Not Applicable|
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 . 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 .
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Trial Appreciating Intramyocardial Haemorrhage in Patients With Primary STEMI and Different Reperfusion Strategies (Pharmaco Invasive Strategy and Primary PCI)|
|Actual Study Start Date :||January 25, 2018|
|Actual Primary Completion Date :||October 30, 2018|
|Actual Study Completion Date :||March 20, 2019|
Experimental: 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.
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.
Active Comparator: Primary PCI
Primary percutaneous coronary intervention (PCI) in patients with primary STEMI
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.
- Intramyocardial haemorrhage in primary STEMI measure [ Time Frame: 2 days ]Intramyocardial haemorrhage (%) in patients with primary STEMI as assessed by cardiac magnetic resonance imaging 2 days after reperfusion
- Left ventricular ejection fraction (LVEF) recovery measure [ 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
- Global Longitudinal Strain [ 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
- Recurrent myocardial infarction measure [ Time Frame: 3 months ]Incidence of recurrent myocardial infarction (%) 3 months after STEMI
- Heart failure incidence measure [ Time Frame: 3 months ]Incidence of heart failure (%) 3 months after STEMI
- Stroke incidence measure [ Time Frame: 3 months ]Incidence of stroke (%) 3 months after STEMI
- Mortality measure [ Time Frame: 3 months ]Mortality rate (%) 3 months after STEMI
- Major bleeding incidence measure [ Time Frame: 3 months ]Incidence of major bleeding (%) 3 months after STEMI
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03677466
|Cardiology Research Institute|
|Tomsk, Russian Federation, 634012|
|Principal Investigator:||Evgeny V. Vyshlov||Tomsk NRMC|