NCT02364687

Brief Summary

Detecting scarred heart muscle is important to diagnose and treat of a wide variety of heart conditions. Magnetic resonance imaging (MRI) can assess scarred heart muscle but it is time consuming, contraindicated for some patients and not tolerated by others. Computed tomography (CT) imaging has the potential to provide a rapid comprehensive assessment of the heart. This study will assess CT imaging of the heart muscle of patients who have previously undergone MRI of their heart. Using a state of the art CT scanner the investigators will develop a low radiation dose protocol to identify scarred heart muscle. The investigators will use and develop software techniques to analyse these images. This will enable us to develop a new way to identify and measure scarred heart muscle that will benefit patients with heart disease.

Trial Health

100
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

Timeline
Completed

Started Oct 2013

Longer than P75 for all trials

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

October 1, 2013

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 10, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 18, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
7.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

June 27, 2023

Status Verified

June 1, 2022

Enrollment Period

2.2 years

First QC Date

February 10, 2015

Last Update Submit

June 26, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Myocardial late enhancement

    The amount of myocardial late enhancement measured on computed tomography as compared to magnetic resonance imaging.

    Immediate

Study Arms (1)

Participants

Participants will have previously had an MRI scan and will undergo a CT scan.

Radiation: Computed tomography late enhancement imaging

Interventions

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have previously undergone magnetic resonance imaging which showed myocardial late enhancement.

You may qualify if:

  • Presence of late enhancement on magnetic resonance imaging

You may not qualify if:

  • age less than 40
  • inability or unwillingness to undergo CT
  • renal failure (serum creatinine \>200 umol/l or estimated glomerular filtration rate \<30 ml/min)
  • hepatic failure
  • allergy to iodinated contrast
  • pregnancy
  • breast feeding
  • inability to undergo informed consent
  • fast atrial fibrillation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Michelle Williams

    University of Edinburgh, NHS Lothian

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2015

First Posted

February 18, 2015

Study Start

October 1, 2013

Primary Completion

December 1, 2015

Study Completion

May 1, 2023

Last Updated

June 27, 2023

Record last verified: 2022-06