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Acute ST-Elevation Myocardial InfarctionMARINA-STEMINCT04113356

Magnetic Resonance Imaging In Acute ST-Elevation Myocardial Infarction

An observational study of Acute ST-Elevation Myocardial Infarction, run by Medical University Innsbruck at 2 sites in Austria.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Cardiovascular magnetic resonance imaging enables comprehensive assessment of cardiovascular function, morphology and pathology. The investigators aim to evaluate the nature and clinical significance of magnetic resonance imaging parameters in patients presenting with first acute ST-elevation myocardial infarction. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute ST-Elevation Myocardial Infarction
What is being tested?
Cardiovascular Magnetic Resonance Imaging
How many people
1,500 participants
Where
2 sitesAustria
Study dates
Jan 2011to Jun 2031
Phase
Observational
Are there results?
Not yet: the study is under way

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

Study population: Patients with acute ST-elevation myocardial infarction treated with primary percutaneous coronary intervention admitted to the coronary care unit of Innsbruck University Hospital for Internal Medicine III (Cardiology and Angiology).

Who may be able to join

  • First ST-elevation myocardial infarction according to the European Society of Cardiology/American College of Cardiology committee criteria
  • Primary percutaneous coronary intervention within 24 hours after symptom onset

Who cannot join

  • Age < 18 years
  • Any history of a previous myocardial infarction or coronary intervention
  • Clinically unstable patients (Killip class >2)
  • Renal failure (estimated glomerular filtration rate < 30 ml/min/1.73 m2)
  • Contraindications to cardiac magnetic resonance imaging (pacemaker, cerebral aneurysm clip, orbital foreign body, known or suggested contrast allergy to gadolinium, claustrophobia)
  • Inability to provide informed consent

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Bernhard Metzler, MD, MSc contact

bernhard.metzler@tirol-kliniken.at

Gert Klug, MD contact

gert.klug@tirol-kliniken.at

Austria2 sites, 2 recruiting

  • University Hospital for Internal Medicine III (Cardiology and Angiology)

    Innsbruck, 6020

    Bernhard Metzler, MD, MSc, bernhard.metzler@tirol-kliniken.at

    Gert Klug, MD

    Recruiting

  • University Hospital for Radiology

    Innsbruck, 6020

    Agnes Mayr, MD, a.mayr@i-med.ac.at

    Agnes Mayr, MD

    Recruiting

Other trials in Austria

About this study

Official title: Clinical Relevance of Magnetic Resonance Imaging in Acute ST-Elevation Myocardial Infarction

Cardiovascular magnetic resonance imaging enables comprehensive assessment of cardiovascular function, morphology and pathology. The investigators aim to evaluate the nature and clinical significance of magnetic resonance imaging parameters in patients presenting with first acute ST-elevation myocardial infarction.

Being tested
Cardiovascular Magnetic Resonance Imaging

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cardiovascular Magnetic Resonance ImagingDiagnostic test

    Cardiovascular magnetic resonance imaging will be performed within the first week after ST-elevation myocardial infarction and in a defined subgroup 4 months, 12 months and 10 years thereafter.

Study groups in NCT04113356
Study groupRoleWhat they receive
ST-Elevation Myocardial InfarctionPatients with acute ST-elevation myocardial infarction treated with primary percutaneous coronary intervention
Receives: Diagnostic Test: Cardiovascular Magnetic Resonance Imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurence of major adverse cardiovascular events

    Measured: 1 - 5 years

Secondary outcomes (20)

  1. Infarct size assessment (% of left ventricular myocardial mass)

    Measured: baseline, 4 months and 12 months

  2. Assessment of infarct transmurality grade (%) with late gadolinium enhancement imaging

    Measured: baseline, 4 months and 12 months

  3. Occurence and area of microvascular obstruction

    Measured: baseline

  4. Intramyocardial haemorrhage assessed by T2* imaging

    Measured: baseline, 4 months and 12 months

  5. Tissue characterisation by T1, T2 and T2* Mapping

    Measured: baseline, 4 months and 12 months

  6. Myocardial deformation by strain analysis

    Measured: baseline, 4 months and 12 months

  7. Chamber volumes by cine imaging

    Measured: baseline, 4 months and 12 months

  8. Cardiac function by cine imaging

    Measured: baseline, 4 months and 12 months

  9. Stroke volumes by phase contrast imaging

    Measured: baseline, 4 months and 12 months

  10. Aortic pulse wave velocity and distensibility by phase contrast imaging

    Measured: baseline, 4 months and 12 months

  11. Aortic pulse wave distensibility by phase contrast imaging

    Measured: baseline, 4 months and 12 months

  12. Quality of life and invalidity assessment (Global Physical Activity Questionnaire)

    Measured: 1 - 5 years

  13. Biomarker release during the acute and subacute phase

    biomarker concentrations of hemodynamic stress (n-terminal pro-B-type natriuretic peptide), neurohumoral markers (i.e. neprilysin ng/ml), inflammatory markers (i.e. procalcitonin µg/l) and markers of myocardial injury (i.e. high sensitivity cardiac troponin T ng/l)

    Measured: baseline, 4 months and 12 months

  14. Parameters of cardiac function by transthoracic echocardiography

    Measured: baseline, 4 months and 12 months

  15. Plaque volume by 3D ultrasound

    Measured: baseline, 12 months

  16. Cardiac autonomic function

    Deceleration capacity of heart rate

    Measured: baseline, 4 months and 12 months

  17. Cardiac autonomic function

    Heart rate variability

    Measured: baseline, 4 months and 12 months

  18. Cardiac autonomic function

    Periodic repolarization dynamics

    Measured: baseline, 4 months and 12 months

  19. Cardiac autonomic function

    Baroreflex sensitivity

    Measured: baseline, 4 months and 12 months

  20. Cardiac autonomic function

    Skin sympathetic nerve activity

    Measured: baseline, 4 months and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2019
  2. Study startJan 2011
  3. Primary completionJun 2026 (estimated)
  4. Study completionJun 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04113356
Sponsor's protocol ID
AN3775
Acronym
MARINA-STEMI
Status last verified
Sep 2021
First submitted
23 Aug 2019
Last updated
10 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Schwab M, Pamminger M, Kremser C, Almar-Munoz E, Reinstadler SJ, Reindl M, Metzler B, Haltmeier M, Mayr A. Association of Deep Learning-based Myocardial Infarction Size Quantification in Cardiac MRI with Cardiac Biomarker Levels. Radiol Cardiothorac Imaging. 2026 Jun;8(3):e250235. doi: 10.1148/ryct.250235.

    PubMed 42347575

  • Lechner I, Reindl M, von der Emde S, Desheva A, Oberhollenzer F, Tiller C, Holzknecht M, Kremser T, Faccini J, Gollmann-Tepekoylu C, Kremser C, Mayr A, Bauer A, Metzler B, Reinstadler SJ. Hepatic Tissue Alterations in ST-Elevation Myocardial Infarction: Determinants and Prognostic Implications. Circ Cardiovasc Imaging. 2024 Dec;17(12):e017041. doi: 10.1161/CIRCIMAGING.124.017041. Epub 2024 Nov 29.

    PubMed 39611252

  • Tiller C, Holzknecht M, Lechner I, Oberhollenzer F, von der Emde S, Kremser T, Gollmann-Tepekoylu C, Mayr A, Bauer A, Metzler B, Reinstadler SJ, Reindl M. Association of Circulating PCSK9 With Ischemia-Reperfusion Injury in Acute ST-Elevation Myocardial Infarction. Circ Cardiovasc Imaging. 2024 Aug;17(8):e016482. doi: 10.1161/CIRCIMAGING.123.016482. Epub 2024 Aug 20.

    PubMed 39163371

  • Holzknecht M, Tiller C, Reindl M, Lechner I, Fink P, Lunger P, Mayr A, Henninger B, Brenner C, Klug G, Bauer A, Metzler B, Reinstadler SJ. Association of C-Reactive Protein Velocity with Early Left Ventricular Dysfunction in Patients with First ST-Elevation Myocardial Infarction. J Clin Med. 2021 Nov 24;10(23):5494. doi: 10.3390/jcm10235494.

    PubMed 34884196

  • Tiller C, Reindl M, Holzknecht M, Lechner I, Schwaiger J, Brenner C, Mayr A, Klug G, Bauer A, Metzler B, Reinstadler SJ. Association of plasma interleukin-6 with infarct size, reperfusion injury, and adverse remodelling after ST-elevation myocardial infarction. Eur Heart J Acute Cardiovasc Care. 2022 Feb 8;11(2):113-123. doi: 10.1093/ehjacc/zuab110.

    PubMed 34849677

  • Lechner I, Reindl M, Tiller C, Holzknecht M, Niederreiter S, Mayr A, Klug G, Brenner C, Bauer A, Metzler B, Reinstadler SJ. Determinants and prognostic relevance of aortic stiffness in patients with recent ST-elevation myocardial infarction. Int J Cardiovasc Imaging. 2022 Jan;38(1):237-247. doi: 10.1007/s10554-021-02383-0. Epub 2021 Sep 2.

    PubMed 34476665

  • Reindl M, Lechner I, Tiller C, Holzknecht M, Rangger A, Mayr A, Theurl M, Klug G, Brenner C, Bauer A, Metzler B, Reinstadler SJ. Glycemic Status and Reperfusion Injury in Patients With ST-Segment Elevation Myocardial Infarction. JACC Cardiovasc Imaging. 2021 Sep;14(9):1875-1877. doi: 10.1016/j.jcmg.2021.04.007. Epub 2021 May 19. No abstract available.

    PubMed 34023265

  • Reindl M, Tiller C, Holzknecht M, Lechner I, Eisner D, Riepl L, Pamminger M, Henninger B, Mayr A, Schwaiger JP, Klug G, Bauer A, Metzler B, Reinstadler SJ. Global longitudinal strain by feature tracking for optimized prediction of adverse remodeling after ST-elevation myocardial infarction. Clin Res Cardiol. 2021 Jan;110(1):61-71. doi: 10.1007/s00392-020-01649-2. Epub 2020 Apr 15.

    PubMed 32296969

Questions about this trial

What is this clinical trial studying?

An observational study of Acute ST-Elevation Myocardial Infarction, run by Medical University Innsbruck at 2 sites in Austria.

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 2 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 10 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Austria. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Bernhard Metzler, MD, MSc (bernhard.metzler@tirol-kliniken.at), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurence of major adverse cardiovascular events (time frame: 1 - 5 years). 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 NCT04113356, which also lists 8 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 10 Sep 2021.

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