Magnetic Resonance Imaging In Acute ST-Elevation Myocardial Infarction

Acute ST-Elevation Myocardial Infarction Clinical Trial

— MARINA-STEMI  

Official title:

Clinical Relevance of Magnetic Resonance Imaging in Acute ST-Elevation Myocardial Infarction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04113356
• Other study ID #: AN3775
• Status: Recruiting
• Start date: January 2011
• Est. completion date: June 2031

Study information

• Verified date: September 2021
• Source: Medical University Innsbruck
• Contact: Bernhard Metzler, MD, MSc
• Email: bernhard.metzler[@]tirol-kliniken.at
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: June 2031
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute ST-Elevation Myocardial Infarction
• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction

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.

Locations

Country	Name	City	State
Austria	University Hospital for Internal Medicine III (Cardiology and Angiology)	Innsbruck
Austria	University Hospital for Radiology	Innsbruck

Sponsors (1)

Lead Sponsor	Collaborator
Medical University Innsbruck

Country where clinical trial is conducted

Austria, 

Outcome

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