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NCT01897350 Clinical Trial

Myocardial Oedema in ST Segment Elevation Myocardial Infarction Myocardial

ST Segment Elevation Myocardial Infarction Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01897350
Other study ID # Study 1953
Secondary ID
Status Completed
Phase N/A
First received July 8, 2013
Last updated October 20, 2014
Start date July 2013

Study information
Verified date October 2014
Source University of Bristol
Contact n/a
Is FDA regulated No
Health authority United Kingdom: National Research Ethics ServiceUnited Kingdom: National Health Service
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date
Est. primary completion date December 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

- STEMI

- providing written informed consent

Exclusion Criteria:

- contraindication to CMR,

- atrial fibrillation,

- claustrophobia,

- eGFR < 30

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• Cardiac magnetic resonance imaging

Locations
Country Name City State
United Kingdom Bristol Heart Institute Bristol Avon

Sponsors (1)
Lead Sponsor Collaborator
Elisa McAlindon

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary The mass of myocardial oedema measured by CMR Day 2 following STEMI No
Secondary Extra cellular volume Day 2 following STEMI No
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