Overview

This trial is active, not recruiting.

Condition acute st-elevation myocardial infarction
Treatments coronary pressure wire, magnetic resonance imaging of the heart
Sponsor NHS National Waiting Times Centre Board
Collaborator Siemens Healthcare Diagnostics Inc
Start date May 2011
End date November 2012
Trial size 324 participants
Trial identifier NCT02072850, 10/S0703/28, Government health research, Research grant number

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Patients presenting with acute-ST elevation myocardial infarction referred for emergency invasive management by primary or rescue percutaneous coronary intervention.
coronary pressure wire Pressure wire Certus (St Jude Medical)
Guidewire-based coronary pressure- and temperature recordings (coronary thermodilution) with and without hyperaemia induced by intravenous administration of adenosine (140 ug/kg/min) in patients with acute ST-elevation myocardial infarction treated by emergency PCI.
magnetic resonance imaging of the heart Cardiac MRI
Cardiac magnetic resonance imaging (MRI) with gadolinium contrast imaging at baseline (~ day 2) and 6 months (all participants) and in 30 subjects at 4 time-points (< 12 hours, days 2, 7-10 and at 6 months).

Primary Outcomes

Measure
Myocardial salvage
time frame: Baseline and 6 months after date of index hospitalisation for STEMI

Secondary Outcomes

Measure
Myocardial salvage index
time frame: Baseline and 6 months
Final infarct size
time frame: MRI scan at 6 months after index hospitalisation
Myocardial haemorrhage
time frame: Baseline MRI scan
Microvascular obstruction
time frame: Baseline MRI scan
First pass MVO
time frame: Baseline MRI
Early MVO
time frame: Baseline MRI
Area-at-risk
time frame: Baseline MRI scan
Myocardial T1 time
time frame: Baseline and follow-up MRI at 6 months
Myocardial T2 time
time frame: Baseline and follow-up MRI at 6 months
Left ventricular ejection fraction
time frame: Baseline and follow-up MRI at 6 months
Left ventricular end-diastolic volume
time frame: Baseline and follow-up MRI at 6 months
Left ventricular end-systolic volume
time frame: Baseline and follow-up MRI at 6 months
Index of microvascular resistance
time frame: Day 0 at initial hospital admission
Quality of life
time frame: Baseline and 6 months
Recurrent myocardial infarction
time frame: 6 months
Adenosine response
time frame: Baseline
MACE
time frame: Minimum 12 months
MACCE
time frame: Minimum 12 months
Serious adverse cardiovascular events.
time frame: Minimum 12 months
All-cause death or heart failure
time frame: Minimum 12 months from baseline

Eligibility Criteria

Male or female participants of any age.

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.

Additional Information

Official title Cardiac Magnetic Resonance Imaging: New Pathological Insights and Their Functional and Clinical Significance in ST Elevation Acute Myocardial Infarction.
Principal investigator Colin Berry, MB ChB BSc PhD FRCP FACC
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by NHS National Waiting Times Centre Board.