Myocardial InfarctionNCT02364687
Optimisation and Quantification of Contrast Enhanced Computed Tomography Myocardial Fibrosis Imaging
An observational study of Myocardial Infarction, run by University of Edinburgh.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Computed tomography late enhancement imaging
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have previously undergone magnetic resonance imaging which showed myocardial late enhancement.
Who may be able to join
- Presence of late enhancement on magnetic resonance imaging
Who cannot join
- 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
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- breast feeding
- inability to undergo informed consent
- fast atrial fibrillation
About this study
Official title: 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.
- Conditions
- Myocardial Infarction
- Being tested
- Computed tomography late enhancement imaging
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed tomography late enhancement imagingRadiation
| Study group | Role | What they receive |
|---|---|---|
| Participants | Participants will have previously had an MRI scan and will undergo a CT scan. Receives: Radiation: Computed tomography late enhancement imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial late enhancement
The amount of myocardial late enhancement measured on computed tomography as compared to magnetic resonance imaging.
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2015 (estimated)
- Study startOct 2013
- Primary completionDec 2015
- Study completionMay 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michelle Williams, Principal investigator, University of Edinburgh, NHS Lothian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02364687
- Sponsor's protocol ID
- 13/SS/0152
- Status last verified
- Jun 2022
- First submitted
- 10 Feb 2015
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimisation and Quantification of Contrast Enhanced Computed Tomography
- ClinicalTrials.gov ID
- NCT02364687
- Acronym / sponsor ID
- 13/SS/0152
- Conditions
- Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- May 2023 (actual)
- First posted
- 18 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | – | Radiation: Computed tomography late enhancement imagingParticipants will have previously had an MRI scan and will undergo a CT scan. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have previously undergone magnetic resonance imaging which showed myocardial late enhancement.
Key inclusion criteria (1 listed)
- Presence of late enhancement on magnetic resonance imaging
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computed tomography late enhancement imaging | Radiation | Participants |
Primary outcome
Myocardial late enhancement
Time frame: Immediate
The amount of myocardial late enhancement measured on computed tomography as compared to magnetic resonance imaging.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Williams principal investigator
University of Edinburgh, NHS Lothian
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction, run by University of Edinburgh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial late enhancement (time frame: Immediate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2023.