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Myocardial Oedema in Acute Myocardial Infarction (AMI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Barts & The London NHS Trust
ClinicalTrials.gov Identifier:
NCT00987259
First received: September 29, 2009
Last updated: January 31, 2013
Last verified: September 2009

September 29, 2009
January 31, 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00987259 on ClinicalTrials.gov Archive Site
Left ventricular ejection fraction and left ventricular scar size at 3 months [ Time Frame: 90 days post MI ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
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
Not Provided
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00987259
BLT006964
No
Barts & The London NHS Trust
Barts & The London NHS Trust
Not Provided
Principal Investigator: Thomas R Burchell, BSc, MB BS Bart's and The London NHS Trust, United Kingdom
Barts & The London NHS Trust
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP