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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Occurence of major adverse cardiovascular events
Time Frame: 1 - 5 years
1 - 5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University Innsbruck

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2011

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 23, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 2, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 10, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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