Clinical trial NCT02072850: Detection and Significance of Heart Injury in ST Elevation Myocardial Infarction.
Official title: Cardiac Magnetic Resonance Imaging: New Pathological Insights and Their Functional and Clinical Significance in ST Elevation Acute Myocardial Infarction.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Acute ST-elevation Myocardial Infarction
Keywords: Myocardial infarction
Primary percutaneous coronary intervention (PCI)
Thrombolysis
Rescue PCI
Electrocardiogram
Magnetic resonance imaging
Area-at-risk
Myocardial salvage
Infarct size
Pressure wire
Coronary thermodilution
Coronary microvascular function
Index of microvascular resistance
Heart failure
Prognosis
Lead sponsor: NHS National Waiting Times Centre Board
Sponsor class: OTHER
Collaborators: name: Siemens Healthcare Diagnostics Inc
name: British Heart Foundation
First posted: 2014-02-27
Enrollment: 324
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of ST-elevation myocardial infarction (STEMI).

Brief summary: Heart imaging with magnetic resonance imaging (MRI) provides detailed insights into heart function and injury. The nature and significance of heart injury after a heart attack is incompletely understood. We propose a 'natural history' study of heart attack injury using contemporary MRI methods. In a large hospital in the West of Scotland, heart attack patients will be invited to have at least two MRI scans and also continue with life-long follow-up. The results from the MRI scans will be assessed with all of the other clinical information obtained at the time of the heart attack and during follow-up. The results of our study should provide new insights into heart attack injury and these results should help improve how heart attack patients should be treated.

Detailed description: Magnetic resonance imaging (MRI) provides detailed insights into soft tissue characteristics and this technique has particular value for imaging patients with acute myocardial infarction (MI). Recent advances in MRI have the potential to reveal new insights into the evolution and functional significance of myocardial injury and repair.

Here, we will study at least 300 consecutive patients with acute ST elevation MI (STEMI) and focus on oedema, scar and bleeding in the heart using MRI in patients managed by emergency percutaneous coronary intervention (PCI). Cardiac MRI scans will be performed at 1.5 Tesla (MAGNETOM, Siemens Healthcare). MRI will be used to assess initial heart function and injury. Myocardial salvage and haemorrhage are prioritised outcomes. Novel MRI methods will also be used to quantify the extent of myocardial jeopardy representing the initial area-at-risk (AAR), and the nature of this injury (strain, haemorrhage). The MRI methods will include T1, T2 and T2\* relaxometry (mapping). Secondly, we will assess coronary artery disease severity by angiography and coronary artery function at the time of the heart attack treatment using a pressure-sensitive coronary guidewire (St Jude Medical). This wire can be used instead of the usual coronary wire and can provide information on heart injury, which can be linked in turn to the MRI findings. All of this information will be linked with health outcomes in the longer term.

We hypothesise that myocardial salvage, oedema, haemorrhage, and strain as revealed by MRI, have functional and prognostic significance. In all patients MRI will be performed at baseline (\~day 2) and again at 6 months. In a subgroup of 30 patients, MRI will be performed on days \<12 hours, and days 2, 7-10 days and 6 months post-MI. A blood and urine sample and quality of life will be obtained at baseline and at 6 months post-MI. Clinical outcomes (e.g. rehospitalisation, death) will be assessed at the end of the study (minimum 1 year) and again during longer term follow-up (minimum 3 years, maximum 20 years) by electronic linkage through central National Health Service (NHS) and government health records in order to determine the long-term prognostic significance of our initial observations with angiography, MRI and the pressure wire. The main statistical analyses will be conducted by an independent trials unit statistician.

Eligibility criteria: Inclusion Criteria:

* Acute STEMI

Exclusion Criteria:

* Major systemic illness (e.g. cancer limiting survival \< 6 months);
* Metallic implant (e.g. cochlear implant);
* Metallic foreign body
* Pregnancy.

Primary outcomes:
measure: Myocardial salvage
timeFrame: Baseline and 6 months after date of index hospitalisation for STEMI
Secondary outcomes:
measure: Myocardial salvage index
timeFrame: Baseline and 6 months
measure: Final infarct size
timeFrame: MRI scan at 6 months after index hospitalisation
measure: Myocardial haemorrhage
timeFrame: Baseline MRI scan
measure: Microvascular obstruction
timeFrame: Baseline MRI scan
measure: First pass MVO
timeFrame: Baseline MRI
measure: Early MVO
timeFrame: Baseline MRI
measure: Area-at-risk
timeFrame: Baseline MRI scan
measure: Myocardial T1 time
timeFrame: Baseline and follow-up MRI at 6 months
measure: Myocardial T2 time
timeFrame: Baseline and follow-up MRI at 6 months
measure: Left ventricular ejection fraction
timeFrame: Baseline and follow-up MRI at 6 months
measure: Left ventricular end-diastolic volume
timeFrame: Baseline and follow-up MRI at 6 months
measure: Left ventricular end-systolic volume
timeFrame: Baseline and follow-up MRI at 6 months
measure: Index of microvascular resistance
timeFrame: Day 0 at initial hospital admission
measure: Quality of life
timeFrame: Baseline and 6 months
measure: Recurrent myocardial infarction
timeFrame: 6 months
measure: Adenosine response
timeFrame: Baseline
measure: MACE
timeFrame: Minimum 12 months
measure: MACCE
timeFrame: Minimum 12 months
measure: Serious adverse cardiovascular events.
timeFrame: Minimum 12 months
measure: All-cause death or heart failure
timeFrame: Minimum 12 months from baseline
Other outcomes:
Locations:
city: Clydebank
country: United Kingdom
facility: Golden Jubilee National Hospital
state: Dunbartonshire
Study officials:
affiliation: University of Glasgow
name: Colin Berry, MB ChB BSc PhD FRCP FACC
role: PRINCIPAL_INVESTIGATOR
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