The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT00987259
Recruitment Status : Completed
First Posted : September 30, 2009
Last Update Posted : February 1, 2013
Sponsor:
Information provided by (Responsible Party):
Barts & The London NHS Trust

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease
Myocardial Infarction

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 20 participants
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
Study Start Date : November 2009
Actual Primary Completion Date : June 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema Heart Attack

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Post MI patients
Patients recruited following a successfully reperfused myocardial infarction using primary angioplasty.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Extent and time course of myocardial oedema over the first 10 days post MI [ Time Frame: Days 1, 3 and 10 post MI ]

Secondary Outcome Measures :
  1. Left ventricular ejection fraction and left ventricular scar size at 3 months [ Time Frame: 90 days post MI ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00987259


Locations
Layout table for location information
United Kingdom
The London Chest Hospital
London, Greater London, United Kingdom, E2 9JX
Sponsors and Collaborators
Barts & The London NHS Trust
Investigators
Layout table for investigator information
Principal Investigator: Thomas R Burchell, BSc, MB BS Bart's and The London NHS Trust, United Kingdom
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Barts & The London NHS Trust
ClinicalTrials.gov Identifier: NCT00987259    
Other Study ID Numbers: BLT006964
First Posted: September 30, 2009    Key Record Dates
Last Update Posted: February 1, 2013
Last Verified: September 2009
Keywords provided by Barts & The London NHS Trust:
Myocardial infarction
Myocardial oedema
Magnetic resonance
Additional relevant MeSH terms:
Layout table for MeSH terms
Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases