AzTrials
AzTrials

Myocardial InfarctionNCT00987259

Myocardial Oedema in Acute Myocardial Infarction (AMI)

An observational study of Myocardial Infarction, run by Barts & The London NHS Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myocardial Infarction
How many people
20 participants
Where
1 siteUnited Kingdom
Study dates
Nov 2009to Oct 2011
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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)
  • At the time of inclusion, the patient no longer requires intravenous catecholamines or mechanical hemodynamic support (aortic balloon pump)
  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • The London Chest Hospital

    London, Greater London, E2 9JX

Other trials in United Kingdom

About this study

Official title: 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.

Read more

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.

Keywords
Myocardial infarction, Myocardial oedema, Magnetic resonance
Medical subject headings
Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00987259
Study groupRoleWhat they receive
Post MI patientsPatients recruited following a successfully reperfused myocardial infarction using primary angioplasty.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Days 1, 3 and 10 post MI

Secondary outcomes (1)

  1. Left ventricular ejection fraction and left ventricular scar size at 3 months

    Measured: 90 days post MI

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2009 (estimated)
  2. Study startNov 2009
  3. Primary completionJun 2011
  4. Study completionOct 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00987259
Sponsor's protocol ID
BLT006964
Status last verified
Sep 2009
First submitted
29 Sep 2009
Last updated
1 Feb 2013
Results posted
No
Data monitoring committee
No

Publications

  • 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. doi: 10.1016/0002-9149(83)90093-0.

    PubMed 6858909

  • Laine GA, Granger HJ. Microvascular, interstitial, and lymphatic interactions in normal heart. Am J Physiol. 1985 Oct;249(4 Pt 2):H834-42. doi: 10.1152/ajpheart.1985.249.4.H834.

    PubMed 4051019

  • 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. doi: 10.1136/heart.85.6.639.

    PubMed 11359743

  • Garcia-Dorado D, Oliveras J, Gili J, Sanz E, Perez-Villa F, Barrabes 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. doi: 10.1093/cvr/27.8.1462.

    PubMed 8297415

  • 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. doi: 10.1136/hrt.2006.102434. Epub 2007 Jul 16.

    PubMed 17639092

  • 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.

    PubMed 15936612

  • 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.

    PubMed 18711021

  • 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.

    PubMed 18852712

  • 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. doi: 10.1097/RLI.0b013e3181558822.

    PubMed 18097272

  • 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. doi: 10.1161/CIRCULATIONAHA.105.576025. Epub 2006 Apr 10.

    PubMed 16606793

  • 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.

    PubMed 18420102

  • 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. doi: 10.1016/s0735-1097(03)00717-4.

    PubMed 12906982

  • Ripa RS, Nilsson JC, Wang Y, Sondergaard L, Jorgensen 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. doi: 10.1016/j.ahj.2007.06.038.

    PubMed 17967600

Questions about this trial

What is this clinical trial studying?

An observational study of Myocardial Infarction, run by Barts & The London NHS Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00987259, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in