Myocardial Oedema in Acute Myocardial Infarction (AMI)

NCT00987259 | Completed

• 1 other identifier: BLT006964
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myocardial Infarction

Keywords

Myocardial infarction; Myocardial oedema; Magnetic resonance

Outcome Measures

Primary Outcomes (1)

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

  Days 1, 3 and 10 post MI

Secondary Outcomes (1)

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

  90 days post MI

Study Arms (1)

Post MI patients

Patients recruited following a successfully reperfused myocardial infarction using primary angioplasty.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to The London Chest Hospital following an ST elevation myocardial infarction who have been successfully treated with primary angioplasty.

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Barts & The London NHS Trust: lead

Study Sites (1)

The London Chest Hospital

London, Greater London, E2 9JX, United Kingdom

Location

Related Publications (13)

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  PMID: 8297415 BACKGROUND

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  PMID: 17639092 BACKGROUND

• Abdel-Aty H, Boye P, Zagrosek A, Wassmuth R, Kumar A, Messroghli D, Bock P, Dietz R, Friedrich MG, Schulz-Menger J. Diagnostic performance of cardiovascular magnetic resonance in patients with suspected acute myocarditis: comparison of different approaches. J Am Coll Cardiol. 2005 Jun 7;45(11):1815-22. doi: 10.1016/j.jacc.2004.11.069.

  PMID: 15936612 BACKGROUND

• Arai AE. Using magnetic resonance imaging to characterize recent myocardial injury: utility in acute coronary syndrome and other clinical scenarios. Circulation. 2008 Aug 19;118(8):795-6. doi: 10.1161/CIRCULATIONAHA.108.797373. No abstract available.

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  PMID: 16606793 BACKGROUND

• Friedrich MG, Abdel-Aty H, Taylor A, Schulz-Menger J, Messroghli D, Dietz R. The salvaged area at risk in reperfused acute myocardial infarction as visualized by cardiovascular magnetic resonance. J Am Coll Cardiol. 2008 Apr 22;51(16):1581-7. doi: 10.1016/j.jacc.2008.01.019.

  PMID: 18420102 BACKGROUND

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  PMID: 17967600 BACKGROUND

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

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

Study Officials

• Thomas R Burchell, BSc, MB BS

  Bart's and The London NHS Trust, United Kingdom

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2009
• First Posted: September 30, 2009
• Study Start: November 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: October 1, 2011
• Last Updated: February 1, 2013

Record last verified: 2009-09

Locations

GB (1)