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Intramyocardial Haemorrhage in Patients With Primary STEMI (HaemInCor)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03677466
Recruitment Status : Completed
First Posted : September 19, 2018
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
Tomsk National Research Medical Center of the Russian Academy of Sciences

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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction STEMI Myocardial Necrosis Myocardial Injury Drug: Pharmaco-invasive strategy Procedure: Primary PCI Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
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.

Other Names:
  • Metalyse
  • Actilyse
  • Tenecteplase
  • Alteplase
  • Streptokinase

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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Russian Federation
Cardiology Research Institute
Tomsk, Russian Federation, 634012
Sponsors and Collaborators
Tomsk National Research Medical Center of the Russian Academy of Sciences
Investigators
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Principal Investigator: Evgeny V. Vyshlov Tomsk NRMC
Publications of Results:
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Responsible Party: Tomsk National Research Medical Center of the Russian Academy of Sciences
ClinicalTrials.gov Identifier: NCT03677466    
Other Study ID Numbers: HaemInCor
First Posted: September 19, 2018    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tomsk National Research Medical Center of the Russian Academy of Sciences:
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
Additional relevant MeSH terms:
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Myocardial Infarction
ST Elevation Myocardial Infarction
Infarction
Hemorrhage
Necrosis
Ischemia
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Tenecteplase
Streptokinase
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action