Clinical trial NCT04113356: Magnetic Resonance Imaging In Acute ST-Elevation Myocardial Infarction
Official title: Clinical Relevance of Magnetic Resonance Imaging in Acute ST-Elevation Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute ST-Elevation Myocardial Infarction
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2019-10-02
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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).

Brief 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.


Eligibility criteria: Inclusion criteria:

* 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

Exclusion criteria:

* 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

Primary outcomes:
measure: Occurence of major adverse cardiovascular events
timeFrame: 1 - 5 years
Secondary outcomes:
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
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
measure: Cardiac autonomic function
timeFrame: baseline, 4 months and 12 months
measure: Cardiac autonomic function
timeFrame: baseline, 4 months and 12 months
measure: Cardiac autonomic function
timeFrame: baseline, 4 months and 12 months
measure: Cardiac autonomic function
timeFrame: baseline, 4 months and 12 months
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: University Hospital for Internal Medicine III (Cardiology and Angiology)
city: Innsbruck
country: Austria
facility: University Hospital for Radiology
Study officials:
affiliation: University Hospital for Internal Medicine III (Cardiology and Angiology)
name: Bernhard Metzler, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.