Myocardial Oedema in Acute Myocardial Infarction (AMI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00987259
Recruitment Status : Completed
First Posted : September 30, 2009
Last Update Posted : February 1, 2013
Information provided by (Responsible Party):
Barts & The London NHS Trust

September 29, 2009
September 30, 2009
February 1, 2013
November 2009
June 2011   (Final data collection date for primary outcome measure)
Extent and time course of myocardial oedema over the first 10 days post MI [ Time Frame: Days 1, 3 and 10 post MI ]
Same as current
Complete list of historical versions of study NCT00987259 on Archive Site
Left ventricular ejection fraction and left ventricular scar size at 3 months [ Time Frame: 90 days post MI ]
Same as current
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Myocardial Oedema in Acute Myocardial Infarction (AMI)
Determination of the Time Course of Myocardial Oedema Post Myocardial Infarction Treated With Primary Angioplasty Using Cardiac Magnetic Resonance Imaging

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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Observational Model: Cohort
Time Perspective: Retrospective
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Non-Probability Sample
Patients admitted to The London Chest Hospital following an ST elevation myocardial infarction who have been successfully treated with primary angioplasty.
Myocardial Infarction
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Post MI patients
Patients recruited following a successfully reperfused myocardial infarction using primary angioplasty.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
October 2011
June 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. 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
  2. Acute PCI / stent implantation has been successful (residual stenosis visually < 30% and TIMI flow ≥ 2)
  3. At the time of inclusion, the patient no longer requires intravenous catecholamines or mechanical hemodynamic support (aortic balloon pump)
  4. Serum troponin >1ng/ml 12 hours after onset of pain
  5. The patient is able to give written informed consent
  6. The patient must be able to understand and communicate in English

Exclusion Criteria:

  1. Known cardiomyopathy
  2. Previous documented myocardial infarction
  3. Previous percutaneous coronary intervention or coronary artery bypass surgery
  4. Significant renal dysfunction (EGFR<30)
  5. Systemic steroid therapy
  6. Current non steroidal anti-inflammatory drug use
  7. Chronic inflammatory disease
  8. Neoplastic disease without documented remission within the past 5 years
  9. Pregnancy
  10. Reduced mental capacity leading to inability to obtain informed consent
  11. Participation in another clinical trial within the last 30 days
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United Kingdom
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Barts & The London NHS Trust
Barts & The London NHS Trust
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Principal Investigator: Thomas R Burchell, BSc, MB BS Bart's and The London NHS Trust, United Kingdom
Barts & The London NHS Trust
September 2009