Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2026-03-01 @ 9:58 AM
Study NCT ID:
NCT04113356
Status:
RECRUITING
Last Update Posted:
2021-09-10
First Post:
2019-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Magnetic Resonance Imaging In Acute ST-Elevation Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2031-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-09', 'studyFirstSubmitDate': '2019-08-23', 'studyFirstSubmitQcDate': '2019-10-01', 'lastUpdatePostDateStruct': {'date': '2021-09-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurence of major adverse cardiovascular events', 'timeFrame': '1 - 5 years'}], 'secondaryOutcomes': [{'measure': 'Infarct size assessment (% of left ventricular myocardial mass)', 'timeFrame': 'baseline, 4 months and 12 months'}, {'measure': 'Assessment of infarct transmurality grade (%) with late gadolinium enhancement imaging', 'timeFrame': 'baseline, 4 months and 12 months'}, {'measure': 'Occurence and area of microvascular obstruction', 'timeFrame': 'baseline'}, {'measure': 'Intramyocardial haemorrhage assessed by T2* imaging', 'timeFrame': 'baseline, 4 months and 12 months'}, {'measure': 'Tissue characterisation by T1, T2 and T2* Mapping', 'timeFrame': 'baseline, 4 months and 12 months'}, {'measure': 'Myocardial deformation by strain analysis', 'timeFrame': 'baseline, 4 months and 12 months'}, {'measure': 'Chamber volumes by cine imaging', 'timeFrame': 'baseline, 4 months and 12 months'}, {'measure': 'Cardiac function by cine imaging', 'timeFrame': 'baseline, 4 months and 12 months'}, {'measure': 'Stroke volumes by phase contrast imaging', 'timeFrame': 'baseline, 4 months and 12 months'}, {'measure': 'Aortic pulse wave velocity and distensibility by phase contrast imaging', 'timeFrame': 'baseline, 4 months and 12 months'}, {'measure': 'Aortic pulse wave distensibility by phase contrast imaging', 'timeFrame': 'baseline, 4 months and 12 months'}, {'measure': 'Quality of life and invalidity assessment (Global Physical Activity Questionnaire)', 'timeFrame': '1 - 5 years'}, {'measure': 'Biomarker release during the acute and subacute phase', 'timeFrame': 'baseline, 4 months and 12 months', 'description': '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)'}, {'measure': 'Parameters of cardiac function by transthoracic echocardiography', 'timeFrame': 'baseline, 4 months and 12 months'}, {'measure': 'Plaque volume by 3D ultrasound', 'timeFrame': 'baseline, 12 months'}, {'measure': 'Cardiac autonomic function', 'timeFrame': 'baseline, 4 months and 12 months', 'description': 'Deceleration capacity of heart rate'}, {'measure': 'Cardiac autonomic function', 'timeFrame': 'baseline, 4 months and 12 months', 'description': 'Heart rate variability'}, {'measure': 'Cardiac autonomic function', 'timeFrame': 'baseline, 4 months and 12 months', 'description': 'Periodic repolarization dynamics'}, {'measure': 'Cardiac autonomic function', 'timeFrame': 'baseline, 4 months and 12 months', 'description': 'Baroreflex sensitivity'}, {'measure': 'Cardiac autonomic function', 'timeFrame': 'baseline, 4 months and 12 months', 'description': 'Skin sympathetic nerve activity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute ST-Elevation Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '39611252', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '39163371', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '34884196', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '34849677', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '34476665', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '34023265', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '32296969', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* First ST-elevation myocardial infarction according to the European Society of Cardiology/American College of Cardiology committee criteria\n* Primary percutaneous coronary intervention within 24 hours after symptom onset\n\nExclusion criteria:\n\n* Age \\< 18 years\n* Any history of a previous myocardial infarction or coronary intervention\n* Clinically unstable patients (Killip class \\>2)\n* Renal failure (estimated glomerular filtration rate \\< 30 ml/min/1.73 m2)\n* Contraindications to cardiac magnetic resonance imaging (pacemaker, cerebral aneurysm clip, orbital foreign body, known or suggested contrast allergy to gadolinium, claustrophobia)\n* Inability to provide informed consent'}, 'identificationModule': {'nctId': 'NCT04113356', 'acronym': 'MARINA-STEMI', 'briefTitle': 'Magnetic Resonance Imaging In Acute ST-Elevation Myocardial Infarction', 'organization': {'class': 'OTHER', 'fullName': 'Medical University Innsbruck'}, 'officialTitle': 'Clinical Relevance of Magnetic Resonance Imaging in Acute ST-Elevation Myocardial Infarction', 'orgStudyIdInfo': {'id': 'AN3775'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ST-Elevation Myocardial Infarction', 'description': 'Patients with acute ST-elevation myocardial infarction treated with primary percutaneous coronary intervention', 'interventionNames': ['Diagnostic Test: Cardiovascular Magnetic Resonance Imaging']}], 'interventions': [{'name': 'Cardiovascular Magnetic Resonance Imaging', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['ST-Elevation Myocardial Infarction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6020', 'city': 'Innsbruck', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Bernhard Metzler, MD, MSc', 'role': 'CONTACT', 'email': 'bernhard.metzler@tirol-kliniken.at'}, {'name': 'Gert Klug, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sebastian Johannes Reinstadler, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Martin Reindl, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Christina Tiller, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Magdalena Holzknecht, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ivan Lechner, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Priscilla Fink, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Hospital for Internal Medicine III (Cardiology and Angiology)', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': '6020', 'city': 'Innsbruck', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Agnes Mayr, MD', 'role': 'CONTACT', 'email': 'a.mayr@i-med.ac.at'}, {'name': 'Agnes Mayr, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mathias Pamminger, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Hospital for Radiology', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}], 'centralContacts': [{'name': 'Bernhard Metzler, MD, MSc', 'role': 'CONTACT', 'email': 'bernhard.metzler@tirol-kliniken.at'}, {'name': 'Gert Klug, MD', 'role': 'CONTACT', 'email': 'gert.klug@tirol-kliniken.at'}], 'overallOfficials': [{'name': 'Bernhard Metzler, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital for Internal Medicine III (Cardiology and Angiology)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University Innsbruck', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}