Intramyocardial Haemorrhage in Patients With Primary STEMI (HaemInCor)

April 4, 2019 updated by: Tomsk National Research Medical Center of the Russian Academy of Sciences

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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:
  • Alteplase
  • Actilyse
  • Metalyse
  • Tenecteplase
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months (with intermediate measurement at day 7 after reperfusion)
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 months (with intermediate measurement at day 7 after reperfusion)
Recurrent myocardial infarction measure
Time Frame: 3 months
Incidence of recurrent myocardial infarction (%) 3 months after STEMI
3 months
Heart failure incidence measure
Time Frame: 3 months
Incidence of heart failure (%) 3 months after STEMI
3 months
Stroke incidence measure
Time Frame: 3 months
Incidence of stroke (%) 3 months after STEMI
3 months
Mortality measure
Time Frame: 3 months
Mortality rate (%) 3 months after STEMI
3 months
Major bleeding incidence measure
Time Frame: 3 months
Incidence of major bleeding (%) 3 months after STEMI
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tomsk National Research Medical Center of the Russian Academy of Sciences

Investigators

  • Principal Investigator: Evgeny V. Vyshlov, Tomsk NRMC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 25, 2018

Primary Completion (ACTUAL)

October 30, 2018

Study Completion (ACTUAL)

March 20, 2019

Study Registration Dates

First Submitted

September 17, 2018

First Submitted That Met QC Criteria

September 17, 2018

First Posted (ACTUAL)

September 19, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 5, 2019

Last Update Submitted That Met QC Criteria

April 4, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HaemInCor

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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