NCT03677466

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 25, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 19, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2019

Completed
Last Updated

April 5, 2019

Status Verified

March 1, 2019

Enrollment Period

9 months

First QC Date

September 17, 2018

Last Update Submit

April 4, 2019

Conditions

Myocardial InfarctionSTEMIMyocardial NecrosisMyocardial Injury

Keywords

Intramyocardial haemorrhageMyocardial InfarctionST Elevation Myocardial InfarctionPrimary Percutaneous Coronary InterventionPharmaco invasive strategyFibrinolytic therapyGlobal longitudinal strainMyocardial NecrosisCoronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Left ventricular ejection fraction (LVEF) recovery measure

    3 months (with intermediate measurement at day 7 after reperfusion)

  • Global Longitudinal Strain

    3 months (with intermediate measurement at day 7 after reperfusion)

  • Recurrent myocardial infarction measure

    3 months

  • Heart failure incidence measure

    3 months

  • Stroke incidence measure

    3 months

  • +2 more secondary outcomes

Study Arms (2)

Pharmaco-invasive strategy

EXPERIMENTAL

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

Primary PCI

ACTIVE COMPARATOR

Primary percutaneous coronary intervention (PCI) in patients with primary STEMI

Procedure: Primary PCI

Interventions

Pharmaco-invasive strategyDRUG

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.

Also known as: Metalyse, Actilyse, Tenecteplase, Alteplase, Streptokinase
Pharmaco-invasive strategy
Primary PCIPROCEDURE

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 PCI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiology Research Institute

Tomsk, 634012, Russia

Location

Related Publications (2)

  • 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.

    PMID: 25212800RESULT

  • 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.

    PMID: 26763281RESULT

MeSH Terms

Conditions

Myocardial InfarctionST Elevation Myocardial InfarctionCoronary Artery Disease

Interventions

TenecteplaseTissue Plasminogen ActivatorStreptokinase

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisCoronary DiseaseArteriosclerosisArterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Serine EndopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesSerine ProteasesPlasminogen ActivatorsBlood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsBiological Factors

Study Officials

  • Evgeny V. Vyshlov

    Tomsk NRMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2018

First Posted

September 19, 2018

Study Start

January 25, 2018

Primary Completion

October 30, 2018

Study Completion

March 20, 2019

Last Updated

April 5, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)