- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02364687
Optimisation and Quantification of Contrast Enhanced Computed Tomography Myocardial Fibrosis Imaging
June 26, 2023 updated by: University of Edinburgh
Optimisation and Quantification of Contrast Enhanced Computed Tomography
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
40
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients who have previously undergone magnetic resonance imaging which showed myocardial late enhancement.
Description
Inclusion Criteria:
- Presence of late enhancement on magnetic resonance imaging
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Participants
Participants will have previously had an MRI scan and will undergo a CT scan.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Myocardial late enhancement
Time Frame: Immediate
|
The amount of myocardial late enhancement measured on computed tomography as compared to magnetic resonance imaging.
|
Immediate
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michelle Williams, University of Edinburgh, NHS Lothian
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2013
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
May 1, 2023
Study Registration Dates
First Submitted
February 10, 2015
First Submitted That Met QC Criteria
February 10, 2015
First Posted (Estimated)
February 18, 2015
Study Record Updates
Last Update Posted (Actual)
June 27, 2023
Last Update Submitted That Met QC Criteria
June 26, 2023
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13/SS/0152
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.