Myocardial Oedema in Acute Myocardial Infarction (AMI)

Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00987259
• Other study ID #: BLT006964
• Status: Completed
• Phase: N/A
• First received: September 29, 2009
• Last updated: January 31, 2013
• Start date: November 2009
• Est. completion date: October 2011

Study information

• Verified date: September 2009
• Source: Barts & The London NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Locations

Country	Name	City	State
United Kingdom	The London Chest Hospital	London	Greater London

Sponsors (1)

Lead Sponsor	Collaborator
Barts & The London NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (13)

Abdel-Aty H, Boyé 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. — View Citation

Aletras AH, Tilak GS, Natanzon A, Hsu LY, Gonzalez FM, Hoyt RF Jr, Arai AE. Retrospective determination of the area at risk for reperfused acute myocardial infarction with T2-weighted cardiac magnetic resonance imaging: histopathological and displacement encoding with stimulated echoes (DENSE) functional validations. Circulation. 2006 Apr 18;113(15):1865-70. Epub 2006 Apr 10. — View Citation

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. — View Citation

Bragadeesh T, Jayaweera AR, Pascotto M, Micari A, Le DE, Kramer CM, Epstein FH, Kaul S. Post-ischaemic myocardial dysfunction (stunning) results from myofibrillar oedema. Heart. 2008 Feb;94(2):166-71. Epub 2007 Jul 16. — View Citation

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. — View Citation

García-Dorado D, Oliveras J, Gili J, Sanz E, Pérez-Villa F, Barrabés J, Carreras MJ, Solares J, Soler-Soler J. Analysis of myocardial oedema by magnetic resonance imaging early after coronary artery occlusion with or without reperfusion. Cardiovasc Res. 1993 Aug;27(8):1462-9. Erratum in: Cardiovasc Res 1993 Oct;27(10):1889. — View Citation

Higgins CB, Herfkens R, Lipton MJ, Sievers R, Sheldon P, Kaufman L, Crooks LE. Nuclear magnetic resonance imaging of acute myocardial infarction in dogs: alterations in magnetic relaxation times. Am J Cardiol. 1983 Jul;52(1):184-8. — View Citation

Klem I, Kim RJ. Assessment of microvascular injury after acute myocardial infarction: importance of the area at risk. Nat Clin Pract Cardiovasc Med. 2008 Dec;5(12):756-7. doi: 10.1038/ncpcardio1373. Epub 2008 Oct 14. — View Citation

Laine GA, Granger HJ. Microvascular, interstitial, and lymphatic interactions in normal heart. Am J Physiol. 1985 Oct;249(4 Pt 2):H834-42. — View Citation

Nilsson JC, Nielsen G, Groenning BA, Fritz-Hansen T, Sondergaard L, Jensen GB, Larsson HB. Sustained postinfarction myocardial oedema in humans visualised by magnetic resonance imaging. Heart. 2001 Jun;85(6):639-42. — View Citation

Ripa RS, Nilsson JC, Wang Y, Søndergaard L, Jørgensen E, Kastrup J. Short- and long-term changes in myocardial function, morphology, edema, and infarct mass after ST-segment elevation myocardial infarction evaluated by serial magnetic resonance imaging. Am Heart J. 2007 Nov;154(5):929-36. — View Citation

Schulz-Menger J, Gross M, Messroghli D, Uhlich F, Dietz R, Friedrich MG. Cardiovascular magnetic resonance of acute myocardial infarction at a very early stage. J Am Coll Cardiol. 2003 Aug 6;42(3):513-8. — View Citation

Tilak GS, Hsu LY, Hoyt RF Jr, Arai AE, Aletras AH. In vivo T2-weighted magnetic resonance imaging can accurately determine the ischemic area at risk for 2-day-old nonreperfused myocardial infarction. Invest Radiol. 2008 Jan;43(1):7-15. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Extent and time course of myocardial oedema over the first 10 days post MI		Days 1, 3 and 10 post MI	No
Secondary	Left ventricular ejection fraction and left ventricular scar size at 3 months		90 days post MI	No