NCT01897350

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

July 8, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 12, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Last Updated

October 21, 2014

Status Verified

October 1, 2014

Enrollment Period

5 months

First QC Date

July 8, 2013

Last Update Submit

October 20, 2014

Conditions

ST Segment Elevation Myocardial InfarctionMyocardial Oedema

Keywords

STEMIMyocardial edemaCardiovascular magnetic resonance

Outcome Measures

Primary Outcomes (1)

  • The mass of myocardial oedema measured by CMR

    Day 2 following STEMI

Secondary Outcomes (1)

  • Extra cellular volume

    Day 2 following STEMI

Study Arms (1)

CMR following ST segment myocardial infarction

Other: Cardiac magnetic resonance imaging

Interventions

Cardiac magnetic resonance imagingOTHER
CMR following ST segment myocardial infarction

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

30 patients will be undergo a CMR scan day 2 following STEMI

You may qualify if:

  • STEMI
  • providing written informed consent

You may not qualify if:

  • contraindication to CMR,
  • atrial fibrillation,
  • claustrophobia,
  • eGFR \< 30

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bristol Heart Institute

Bristol, Avon, BS2 8HW, United Kingdom

Location

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

July 8, 2013

First Posted

July 12, 2013

Study Start

July 1, 2013

Primary Completion

December 1, 2013

Last Updated

October 21, 2014

Record last verified: 2014-10

Locations

GB(1)