Intramyocardial Haemorrhage in Patients With Primary STEMI

Myocardial Infarction Clinical Trial

— HaemInCor  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03677466
• Other study ID #: HaemInCor
• Status: Completed
• Phase: N/A
• Start date: January 25, 2018
• Est. completion date: March 20, 2019

Study information

• Verified date: March 2019
• Source: Tomsk National Research Medical Center of the Russian Academy of Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 20, 2019
• Est. primary completion date: October 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Infarction
• Myocardial Infarction
• Myocardial Injury
• Myocardial Necrosis
• Necrosis
• ST Elevation Myocardial Infarction
• STEMI

Intervention

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.

Locations

Country	Name	City	State
Russian Federation	Cardiology Research Institute	Tomsk

Sponsors (1)

Lead Sponsor	Collaborator
Tomsk National Research Medical Center of the Russian Academy of Sciences

Country where clinical trial is conducted

Russian Federation, 

References & Publications (2)

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- — View 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):9 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intramyocardial haemorrhage in primary STEMI measure	Intramyocardial haemorrhage (%) in patients with primary STEMI as assessed by cardiac magnetic resonance imaging 2 days after reperfusion	2 days
Secondary	Left ventricular ejection fraction (LVEF) recovery measure	Left ventricular ejection fraction (LVEF) (%) recovery measured with echocardiography 7 days and 3 months after reperfusion strategies	3 months (with intermediate measurement at day 7 after reperfusion)
Secondary	Global Longitudinal Strain	Global Longitudinal Strain (%) measured with echocardiography 7 days and 3 months after reperfusion strategies	3 months (with intermediate measurement at day 7 after reperfusion)
Secondary	Recurrent myocardial infarction measure	Incidence of recurrent myocardial infarction (%) 3 months after STEMI	3 months
Secondary	Heart failure incidence measure	Incidence of heart failure (%) 3 months after STEMI	3 months
Secondary	Stroke incidence measure	Incidence of stroke (%) 3 months after STEMI	3 months
Secondary	Mortality measure	Mortality rate (%) 3 months after STEMI	3 months
Secondary	Major bleeding incidence measure	Incidence of major bleeding (%) 3 months after STEMI	3 months