NCT01468662

Brief Summary

The investigators propose to conduct a study to measure the reproducibility of CMR parameters that have been used to predict outcome following PPCI: infarct size, left ventricular volumes, myocardial salvage, microvascular obstruction (MVO) and myocardial oedema.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 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

November 1, 2011

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 9, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Last Updated

October 28, 2014

Status Verified

October 1, 2014

Enrollment Period

1.4 years

First QC Date

November 7, 2011

Last Update Submit

October 27, 2014

Conditions

STEMI

Outcome Measures

Primary Outcomes (1)

  • Inter-observer, intra-observer and inter-scan variability and agreement

    Between 2 scans

Study Arms (1)

STEMI

Eligibility Criteria

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

ST segment elevation myocardial infarction

You may qualify if:

  • Participant may enter study if ALL of the following apply
  • ST segment myocardial infarction as defined by ECG (by 2 contiguous limb leads with \>1 mm ST-segment elevation, or \>2 mm ST-segment elevation in contiguous precordial leads, or new LBBB) and \> 20 minutes of cardiac chest pain
  • Written informed consent

You may not qualify if:

  • Participant may not enter study if ANY of the following apply
  • Contraindication to MRI (implanted pacemaker/ defibrillator, ferromagnetic metal implant/ injury, claustrophobia, obesity/ too large for CMR scanner)
  • Known allergy to gadolinium
  • Chronic atrial fibrillation
  • Renal impairment with eGFR \<30
  • Cardiogenic shock
  • Patients with special communication needs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bristol Heart Institute

Bristol, BS2 8HW, United Kingdom

Location

Related Publications (1)

  • McAlindon EJ, Pufulete M, Harris JM, Lawton CB, Moon JC, Manghat N, Hamilton MC, Weale PJ, Bucciarelli-Ducci C. Measurement of myocardium at risk with cardiovascular MR: comparison of techniques for edema imaging. Radiology. 2015 Apr;275(1):61-70. doi: 10.1148/radiol.14131980. Epub 2014 Oct 21.

    PMID: 25333474DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

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

Study Officials

  • Elisa McAlindon, BMBS

    University of Bristol

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cardiology Clinical Research Fellow

Study Record Dates

First Submitted

November 7, 2011

First Posted

November 9, 2011

Study Start

November 1, 2011

Primary Completion

April 1, 2013

Last Updated

October 28, 2014

Record last verified: 2014-10

Locations

GB(1)