Myocardial Oedema in Acute Myocardial Infarction (AMI)

Despite recent improvements in treatment, myocardial infarction (heart attack) is still a leading cause of illness and death in the UK. Following the acute event, it is difficult to predict which patients are at risk of further problems, such as heart failure and is therefore difficult to know which patients need more aggressive/intensive treatment and monitoring.

There needs to be a test which is safe, reliable and reproducible that can be used shortly after a heart attack to both predict future cardiac events and to allow the efficacy of new treatments to be assessed.

Myocardial oedema (swelling of the heart muscle) has been demonstrated using Cardiac Magnetic Resonance (CMR), to occur following a heart attack and has been suggested as a marker for future cardiac events. The optimum time to perform this scan, the method of data analysis and it's effectiveness as a predictor of future cardiac events has not been adequately assessed.

This trial will assess the amount and natural time-course of oedema in the first 10 days following a heart attack. It will also correlate the amount of oedema with the size of scar (damaged heart muscle) and left ventricular ejection fraction (heart function) at 3 months to assess if it is a predictive marker.

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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The London Chest Hospital

London, Greater London, E2 9JX, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients presenting to the London Chest Hospital with acute ST elevation myocardial infarction and treated with primary angioplasty and stent implantation within 12 hours of symptom onset
Acute PCI / stent implantation has been successful (residual stenosis visually < 30% and TIMI flow ≥ 2)
At the time of inclusion, the patient no longer requires intravenous catecholamines or mechanical hemodynamic support (aortic balloon pump)
Serum troponin >1ng/ml 12 hours after onset of pain
The patient is able to give written informed consent
The patient must be able to understand and communicate in English

Exclusion criteria

Known cardiomyopathy
Previous documented myocardial infarction
Previous percutaneous coronary intervention or coronary artery bypass surgery
Significant renal dysfunction (EGFR<30)
Systemic steroid therapy
Current non steroidal anti-inflammatory drug use
Chronic inflammatory disease
Neoplastic disease without documented remission within the past 5 years
Pregnancy
Reduced mental capacity leading to inability to obtain informed consent
Participation in another clinical trial within the last 30 days

Treatment and study plan

Primary outcomes

Extent and time course of myocardial oedema over the first 10 days post MI

Time frame: Days 1, 3 and 10 post MI

Secondary outcomes

Left ventricular ejection fraction and left ventricular scar size at 3 months

Time frame: 90 days post MI

Sponsors and collaborators

Lead sponsor

Barts & The London NHS Trust

Other

Registry information

Official study title

Determination of the Time Course of Myocardial Oedema Post Myocardial Infarction Treated With Primary Angioplasty Using Cardiac Magnetic Resonance Imaging

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2011
First posted: Sep 30, 2009
Registry last updated: Feb 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed