We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Myocardial Oedema in ST Segment Elevation Myocardial Infarction Myocardial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01897350
First Posted: July 12, 2013
Last Update Posted: October 21, 2014
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.
Information provided by (Responsible Party):
Elisa McAlindon, University of Bristol
  Purpose
Cardiac magnetic resonance imaging (CMR) is a non invasive technique used to obtain functional and anatomical information on the heart. Several CMR parameters measured after primary percutaneous coronary intervention (PPCI) have been shown to have prognostic value and are increasingly being used as surrogate endpoints in clinical trials. Myocardial oedema is a prognostic indicator following myocardial infarction1. Myocardial salvage is calculated as the myocardial oedema minus infarct size; this again is a prognostic indicator following STEMI. However, myocardial oedema imaging is controversial. There are multiple sequences available, with no standardisation of sequences used to assess this surrogate endpoint. The investigators propose to conduct a study to measure the myocardial oedema by all available techniques to determine the agreement between these methods.

Condition Intervention
ST Segment Elevation Myocardial Infarction Myocardial Oedema Other: Cardiac magnetic resonance imaging

Study Type: Observational
Study Design: Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Elisa McAlindon, University of Bristol:

Primary Outcome Measures:
  • The mass of myocardial oedema measured by CMR [ Time Frame: Day 2 following STEMI ]

Secondary Outcome Measures:
  • Extra cellular volume [ Time Frame: Day 2 following STEMI ]

Enrollment: 30
Study Start Date: July 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
CMR following ST segment myocardial infarction Other: Cardiac magnetic resonance imaging

  Eligibility

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.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
30 patients will be undergo a CMR scan day 2 following STEMI
Criteria

Inclusion Criteria:

  • STEMI
  • providing written informed consent

Exclusion Criteria:

  • contraindication to CMR,
  • atrial fibrillation,
  • claustrophobia,
  • eGFR < 30
  Contacts and Locations
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): NCT01897350


Locations
United Kingdom
Bristol Heart Institute
Bristol, Avon, United Kingdom, BS2 8HW
Sponsors and Collaborators
Elisa McAlindon
  More Information

Responsible Party: Elisa McAlindon, principle investigator, University of Bristol
ClinicalTrials.gov Identifier: NCT01897350     History of Changes
Other Study ID Numbers: Study 1953
First Submitted: July 8, 2013
First Posted: July 12, 2013
Last Update Posted: October 21, 2014
Last Verified: October 2014

Keywords provided by Elisa McAlindon, University of Bristol:
STEMI
Myocardial edema
Cardiovascular magnetic resonance

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