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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
History of Changes
  Purpose

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.


Condition
Myocardial Infarction

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Determination of the Time Course of Myocardial Oedema Post Myocardial Infarction Treated With Primary Angioplasty Using Cardiac Magnetic Resonance Imaging

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Barts & The London NHS Trust:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Left ventricular ejection fraction and left ventricular scar size at 3 months [ Time Frame: 90 days post MI ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: November 2009
Study Completion Date: October 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Post MI patients
Patients recruited following a successfully reperfused myocardial infarction using primary angioplasty.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00987259

Locations
United Kingdom
The London Chest Hospital
London, Greater London, United Kingdom, E2 9JX
Sponsors and Collaborators
Barts & The London NHS Trust
Investigators
Principal Investigator: Thomas R Burchell, BSc, MB BS Bart's and The London NHS Trust, United Kingdom
  More Information

Publications:

Responsible Party: Barts & The London NHS Trust
ClinicalTrials.gov Identifier: NCT00987259     History of Changes
Other Study ID Numbers: BLT006964
Study First Received: September 29, 2009
Last Updated: January 31, 2013
Health Authority: United Kingdom: National Health Service

Keywords provided by Barts & The London NHS Trust:
Myocardial infarction
Myocardial oedema
Magnetic resonance

Additional relevant MeSH terms:
Edema
Infarction
Myocardial Infarction
Signs and Symptoms
Ischemia
Pathologic Processes
 Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013