Myocardial InfarctionHaemInCorNCT03677466
Intramyocardial Haemorrhage in Patients With Primary STEMI
A study testing Pharmaco-invasive strategy and Primary PCI in people with Myocardial Infarction and STEMI, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction, STEMI, Myocardial Necrosis
- What is being tested?
- Pharmaco-invasive strategy and Primary PCI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteRussia
- Study dates
- 25 Jan 2018to 20 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Myocardial Infarction, STEMI, Myocardial Necrosis, Myocardial Injury
- Being tested
- Pharmaco-invasive strategy, Primary PCI
- Keywords
- 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
- Medical subject headings
- Myocardial Infarction, ST Elevation Myocardial Infarction, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmaco-invasive strategyDrug
Also called Metalyse, Actilyse, Tenecteplase, Alteplase
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.
Primary PCIProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Pharmaco-invasive strategy |
| Primary PCI | Active comparator | Primary percutaneous coronary intervention (PCI) in patients with primary STEMI Receives: Procedure: Primary PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intramyocardial haemorrhage in primary STEMI measure
Intramyocardial haemorrhage (%) in patients with primary STEMI as assessed by cardiac magnetic resonance imaging 2 days after reperfusion
Measured: 2 days
Secondary outcomes (7)
Left ventricular ejection fraction (LVEF) recovery measure
Left ventricular ejection fraction (LVEF) (%) recovery measured with echocardiography 7 days and 3 months after reperfusion strategies
Measured: 3 months (with intermediate measurement at day 7 after reperfusion)
Global Longitudinal Strain
Global Longitudinal Strain (%) measured with echocardiography 7 days and 3 months after reperfusion strategies
Measured: 3 months (with intermediate measurement at day 7 after reperfusion)
Recurrent myocardial infarction measure
Incidence of recurrent myocardial infarction (%) 3 months after STEMI
Measured: 3 months
Heart failure incidence measure
Incidence of heart failure (%) 3 months after STEMI
Measured: 3 months
Stroke incidence measure
Incidence of stroke (%) 3 months after STEMI
Measured: 3 months
Mortality measure
Mortality rate (%) 3 months after STEMI
Measured: 3 months
Major bleeding incidence measure
Incidence of major bleeding (%) 3 months after STEMI
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study start25 Jan 2018
- Primary completion30 Oct 2018
- Study completion20 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Evgeny V. Vyshlov, Principal investigator, Tomsk NRMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03677466
- Sponsor's protocol ID
- CRI-5
- Acronym
- HaemInCor
- Status last verified
- Jun 2026
- First submitted
- 17 Sep 2018
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25212800Carrick 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.
PubMed 26763281
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial Appreciating Intramyocardial Haemorrhage in Patients With Primary STEMI and Different Reperfusion Strategies (Pharmaco Invasive Strategy and Primary PCI)
- ClinicalTrials.gov ID
- NCT03677466
- Acronym / sponsor ID
- HaemInCor / CRI-5
- Conditions
- Myocardial Infarction, STEMI, Myocardial Necrosis, Myocardial Injury
- Keywords
- Intramyocardial haemorrhage, Myocardial Infarction, ST Elevation Myocardial Infarction, Primary Percutaneous Coronary Intervention, Pharmaco invasive strategy, Fibrinolytic therapy, Global longitudinal strain, Myocardial Necrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of SciencesUniversity, hospital or other
- Study start
- 25 Jan 2018 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 20 Mar 2019 (actual)
- First posted
- 19 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to assess the frequency and intensity of intramyocardial haemorrhage in patients with primary STEMI and different reperfusion strategies.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmaco-invasive strategy | Experimental | Drug: Pharmaco-invasive strategyFibrinolytic 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. |
| Primary PCI | Active comparator | Procedure: Primary PCIPrimary percutaneous coronary intervention (PCI) in patients with primary STEMI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (15 listed)
- Inability to obtain informed consent;
- Patients previously undergone endovascular / surgical revascularization of coronary artery;
- Severe comorbidity;
- History of myocardial infarction;
- History of intracranial haemorrhage;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmaco-invasive strategyAlso: Metalyse, Actilyse, Tenecteplase, AlteplasePatient 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. | Drug | Pharmaco-invasive strategy |
| Primary PCIAfter 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. | Procedure or surgery | Primary PCI |
Primary outcome
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
7 secondary outcomes
Left ventricular ejection fraction (LVEF) recovery measure
Time frame: 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)
Recurrent myocardial infarction measure
Time frame: 3 months
Heart failure incidence measure
Time frame: 3 months
Stroke incidence measure
Time frame: 3 months
Mortality measure
Time frame: 3 months
Major bleeding incidence measure
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Results publication: PubMed 25212800Hamirani 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.
- Results publication: PubMed 26763281Carrick 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evgeny V. Vyshlov principal investigator
Tomsk NRMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmaco-invasive strategy and Primary PCI in people with Myocardial Infarction and STEMI, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intramyocardial haemorrhage in primary STEMI measure (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03677466, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.