Myocardial Oedema in ST Segment Elevation Myocardial Infarction Myocardial

This study is not yet open for participant recruitment.
Verified July 2013 by University of Bristol
Sponsor:
Information provided by (Responsible Party):
Elisa McAlindon, University of Bristol
ClinicalTrials.gov Identifier:
NCT01897350
First received: July 8, 2013
Last updated: July 11, 2013
Last verified: July 2013
  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 University of Bristol:

Primary Outcome Measures:
  • The mass of myocardial oedema measured by CMR [ Time Frame: Day 2 following STEMI ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Extra cellular volume [ Time Frame: Day 2 following STEMI ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: July 2013
Estimated 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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01897350

Contacts
Contact: Elisa McAlindon, BMBS +441173425888 elisa.mcalindon@bristol.ac.uk

Locations
United Kingdom
Bristol Heart Institute Not yet recruiting
Bristol, Avon, United Kingdom, BS2 8HW
Contact: Elisa McAlindon, BMBS    +441173425888    elisa.mcalindon@bristol.ac.uk   
Principal Investigator: Elisa McAlindon, BMBS         
Sponsors and Collaborators
Elisa McAlindon
  More Information

No publications provided

Responsible Party: Elisa McAlindon, principle investigator, University of Bristol
ClinicalTrials.gov Identifier: NCT01897350     History of Changes
Other Study ID Numbers: Study 1953
Study First Received: July 8, 2013
Last Updated: July 11, 2013
Health Authority: United Kingdom: National Research Ethics Service
United Kingdom: National Health Service

Keywords provided by University of Bristol:
STEMI
Myocardial edema
Cardiovascular 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 April 21, 2014