NCT04113356

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
62mo left

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

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 Progress75%
Jan 2011Jun 2031

Study Start

First participant enrolled

January 1, 2011

Completed
8.6 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 2, 2019

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2031

Last Updated

September 10, 2021

Status Verified

September 1, 2021

Enrollment Period

15.4 years

First QC Date

August 23, 2019

Last Update Submit

September 9, 2021

Conditions

Acute ST-Elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • Occurence of major adverse cardiovascular events

    1 - 5 years

Secondary Outcomes (20)

  • Infarct size assessment (% of left ventricular myocardial mass)

    baseline, 4 months and 12 months

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

    baseline, 4 months and 12 months

  • Occurence and area of microvascular obstruction

    baseline

  • Intramyocardial haemorrhage assessed by T2* imaging

    baseline, 4 months and 12 months

  • Tissue characterisation by T1, T2 and T2* Mapping

    baseline, 4 months and 12 months

  • +15 more secondary outcomes

Study Arms (1)

ST-Elevation Myocardial Infarction

Patients with acute ST-elevation myocardial infarction treated with primary percutaneous coronary intervention

Diagnostic Test: Cardiovascular Magnetic Resonance Imaging

Interventions

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.

ST-Elevation Myocardial Infarction

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital for Internal Medicine III (Cardiology and Angiology)

Innsbruck, 6020, Austria

RECRUITING

University Hospital for Radiology

Innsbruck, 6020, Austria

RECRUITING

Related Publications (7)

  • 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: 39611252DERIVED

  • 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: 39163371DERIVED

  • 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: 34884196DERIVED

  • 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: 34849677DERIVED

  • 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: 34476665DERIVED

  • 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: 34023265DERIVED

  • 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.

    PMID: 32296969DERIVED

Study Officials

  • Bernhard Metzler, MD, MSc

    University Hospital for Internal Medicine III (Cardiology and Angiology)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bernhard Metzler, MD, MSc

CONTACT

bernhard.metzler@tirol-kliniken.at

Gert Klug, MD

CONTACT

gert.klug@tirol-kliniken.at

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2019

First Posted

October 2, 2019

Study Start

January 1, 2011

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2031

Last Updated

September 10, 2021

Record last verified: 2021-09

Locations

AU(2)