Clinical trial NCT03677466: Intramyocardial Haemorrhage in Patients With Primary STEMI
Official title: Clinical Trial Appreciating Intramyocardial Haemorrhage in Patients With Primary STEMI and Different Reperfusion Strategies (Pharmaco Invasive Strategy and Primary PCI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Infarction
STEMI
Myocardial Necrosis
Myocardial Injury
Keywords: 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
Lead sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences
Sponsor class: OTHER
First posted: 2018-09-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Intramyocardial haemorrhage in primary STEMI measure
timeFrame: 2 days
Secondary outcomes:
measure: Left ventricular ejection fraction (LVEF) recovery measure
timeFrame: 3 months (with intermediate measurement at day 7 after reperfusion)
measure: Global Longitudinal Strain
timeFrame: 3 months (with intermediate measurement at day 7 after reperfusion)
measure: Recurrent myocardial infarction measure
timeFrame: 3 months
measure: Heart failure incidence measure
timeFrame: 3 months
measure: Stroke incidence measure
timeFrame: 3 months
measure: Mortality measure
timeFrame: 3 months
measure: Major bleeding incidence measure
timeFrame: 3 months
Other outcomes:
Locations:
city: Tomsk
country: Russian Federation
facility: Cardiology Research Institute
Study officials:
affiliation: Tomsk NRMC
name: Evgeny V. Vyshlov
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hamirani YS, Wong A, Kramer CM, Salerno M. Effect of microvascular obstruction and intramyocardial hemorrhage by CMR on LV remodeling and outcomes after myocardial infarction: a systematic review and meta-analysis. JACC Cardiovasc Imaging. 2014 Sep;7(9):940-52. doi: 10.1016/j.jcmg.2014.06.012.
citation: Carrick D, Haig C, Ahmed N, McEntegart M, Petrie MC, Eteiba H, Hood S, Watkins S, Lindsay MM, Davie A, Mahrous A, Mordi I, Rauhalammi S, Sattar N, Welsh P, Radjenovic A, Ford I, Oldroyd KG, Berry C. Myocardial Hemorrhage After Acute Reperfused ST-Segment-Elevation Myocardial Infarction: Relation to Microvascular Obstruction and Prognostic Significance. Circ Cardiovasc Imaging. 2016 Jan;9(1):e004148. doi: 10.1161/CIRCIMAGING.115.004148.