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Completed

NCT Number: NCT03677466

Intramyocardial Haemorrhage in Patients With Primary STEMI

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pharmaco-invasive strategy

Drug

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.

Other names: Metalyse, Actilyse, Tenecteplase, Alteplase, Streptokinase

Primary PCI

Procedure

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. Recurrent myocardial infarction measure

    Time frame: 3 months

    Incidence of recurrent myocardial infarction (%) 3 months after STEMI

  4. Heart failure incidence measure

    Time frame: 3 months

    Incidence of heart failure (%) 3 months after STEMI

  5. Stroke incidence measure

    Time frame: 3 months

    Incidence of stroke (%) 3 months after STEMI

  6. Mortality measure

    Time frame: 3 months

    Mortality rate (%) 3 months after STEMI

  7. Major bleeding incidence measure

    Time frame: 3 months

    Incidence of major bleeding (%) 3 months after STEMI

Sponsors and collaborators

Lead sponsor

Tomsk National Research Medical Center of the Russian Academy of Sciences

Other

Registry information

Official study title

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

Acronym: HaemInCor

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Sep 19, 2018
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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