Magnetic Resonance Imaging In Acute ST-Elevation Myocardial Infarction (MARINA-STEMI)

September 9, 2021 updated by: Medical University Innsbruck

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Austria
      • Innsbruck, Austria, 6020
        • Recruiting
        • University Hospital for Internal Medicine III (Cardiology and Angiology)
        • Sub-Investigator:
          • Gert Klug, MD
        • Sub-Investigator:
          • Martin Reindl, MD, PhD
        • Sub-Investigator:
          • Ivan Lechner, MD
        • Sub-Investigator:
          • Magdalena Holzknecht, MD
        • Contact:
        • Sub-Investigator:
          • Sebastian Johannes Reinstadler, MD, PhD
        • Sub-Investigator:
          • Christina Tiller, MD, PhD
        • Sub-Investigator:
          • Priscilla Fink, MD
      • Innsbruck, Austria, 6020
        • Recruiting
        • University Hospital for Radiology
        • Sub-Investigator:
          • Agnes Mayr, MD
        • Contact:
        • Sub-Investigator:
          • Mathias Pamminger, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ST-Elevation Myocardial Infarction
Patients with acute ST-elevation myocardial infarction treated with primary percutaneous coronary intervention
Diagnostic test: Cardiovascular Magnetic Resonance Imaging
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurence of major adverse cardiovascular events
Time Frame: 1 - 5 years
1 - 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infarct size assessment (% of left ventricular myocardial mass)
Time Frame: baseline, 4 months and 12 months
baseline, 4 months and 12 months
Assessment of infarct transmurality grade (%) with late gadolinium enhancement imaging
Time Frame: baseline, 4 months and 12 months
baseline, 4 months and 12 months
Occurence and area of microvascular obstruction
Time Frame: baseline
baseline
Intramyocardial haemorrhage assessed by T2* imaging
Time Frame: baseline, 4 months and 12 months
baseline, 4 months and 12 months
Tissue characterisation by T1, T2 and T2* Mapping
Time Frame: baseline, 4 months and 12 months
baseline, 4 months and 12 months
Myocardial deformation by strain analysis
Time Frame: baseline, 4 months and 12 months
baseline, 4 months and 12 months
Chamber volumes by cine imaging
Time Frame: baseline, 4 months and 12 months
baseline, 4 months and 12 months
Cardiac function by cine imaging
Time Frame: baseline, 4 months and 12 months
baseline, 4 months and 12 months
Stroke volumes by phase contrast imaging
Time Frame: baseline, 4 months and 12 months
baseline, 4 months and 12 months
Aortic pulse wave velocity and distensibility by phase contrast imaging
Time Frame: baseline, 4 months and 12 months
baseline, 4 months and 12 months
Aortic pulse wave distensibility by phase contrast imaging
Time Frame: baseline, 4 months and 12 months
baseline, 4 months and 12 months
Quality of life and invalidity assessment (Global Physical Activity Questionnaire)
Time Frame: 1 - 5 years
1 - 5 years
Biomarker release during the acute and subacute phase
Time Frame: baseline, 4 months and 12 months
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)
baseline, 4 months and 12 months
Parameters of cardiac function by transthoracic echocardiography
Time Frame: baseline, 4 months and 12 months
baseline, 4 months and 12 months
Plaque volume by 3D ultrasound
Time Frame: baseline, 12 months
baseline, 12 months
Cardiac autonomic function
Time Frame: baseline, 4 months and 12 months
Deceleration capacity of heart rate
baseline, 4 months and 12 months
Cardiac autonomic function
Time Frame: baseline, 4 months and 12 months
Heart rate variability
baseline, 4 months and 12 months
Cardiac autonomic function
Time Frame: baseline, 4 months and 12 months
Periodic repolarization dynamics
baseline, 4 months and 12 months
Cardiac autonomic function
Time Frame: baseline, 4 months and 12 months
Baroreflex sensitivity
baseline, 4 months and 12 months
Cardiac autonomic function
Time Frame: baseline, 4 months and 12 months
Skin sympathetic nerve activity
baseline, 4 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University Innsbruck

Investigators

  • Principal Investigator: Bernhard Metzler, MD, MSc, University Hospital for Internal Medicine III (Cardiology and Angiology)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2011

Primary Completion (Anticipated)

June 1, 2026

Study Completion (Anticipated)

June 1, 2031

Study Registration Dates

First Submitted

August 23, 2019

First Submitted That Met QC Criteria

October 1, 2019

First Posted (Actual)

October 2, 2019

Study Record Updates

Last Update Posted (Actual)

September 10, 2021

Last Update Submitted That Met QC Criteria

September 9, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AN3775

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute ST-Elevation Myocardial Infarction

Clinical Trials on Cardiovascular Magnetic Resonance Imaging

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritius

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe