AtherosclerosisNCT06718465
Integrated Informatics-imaging Approaches to Cardiovascular Disease.
An observational study of Atherosclerosis and Myocardial Infarction, run by University of Edinburgh.
Trial summary
Hardening of the arteries (atherosclerosis) is a common disorder that causes heart attacks. In the United Kingdom heart attacks are the commonest cause of death. Combined positron emission tomography (PET) and computer tomography (CT) scans are a new way of assessing atherosclerosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerosis, Myocardial Infarction, Sudden Cardiac Death
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 9 Nov 2016to 9 Nov 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include sudden death victims who have died in the community.
Who may be able to join
- Sudden death victims dying in the community. Patients with or without a history of ischaemic heart disease.
Who cannot join
- Age under 18 years old. Suspicion around the cause of death, or cases of homicide.
About this study
Official title: Development of Combined Imaging and Informatics Based Approaches to Understanding Cardiovascular Disease.
Hardening of the arteries (atherosclerosis) is a common disorder that causes heart attacks. In the United Kingdom heart attacks are the commonest cause of death. Combined positron emission tomography (PET) and computer tomography (CT) scans are a new way of assessing atherosclerosis. Using the radiotracer 18F-Fluoride, this study proposes to perform combined PET CT scans on post-mortem hearts from participants with or without a history of heart disease. It will then be able to compare the hot spots found on these scans with what investigators can see under the microscope when looking at heart artery specimens, assess which genes are switched on and proteins present in the hot spots. This will give us an insight into what hot spots on PET CT scans are identifying in areas of atherosclerosis. It will also provide new information relating to the underlying processes that give rise to atherosclerosis and the development of heart attacks. This will pave the way for the future development of new treatments.
Read the detailed description
Hardening of the arteries (atherosclerosis) is a very common health problem that can lead to fatal or disabling heart attacks or strokes. On many levels, it remains an incompletely understood illness.
Until relatively recently, the only way of assessing the severity of, or risk posed by, atherosclerosis was to measure the degree to which it narrowed a particular blood vessel. This method only tells part of the story; investigators now know that frequently the 'culprit area' of atherosclerosis that causes a heart attack or stroke doesn't necessarily result in narrowing of the blood vessel i.e. if investigators only measure narrowness they will miss lots of 'bad' atherosclerosis.
Combined PET CT scans not only provide more information about the composition and architecture of the atherosclerosis but can provide data about the processes (at the chemical and cellular level) that underlie the disease. Hardened arteries with areas of early calcification (deposits of calcium) are usually the culprits that lead to heart attacks. Early calcification can be detected using 18F-Fluoride PET CT scans. It has previously been described by the Chief Investigator and colleagues that hot spots on 18F-Fluoride PET CT scans are associated with rupture of hardened arteries in stroke patients.
The aim of this study is to explore whether hot spots on 18F-Fluoride PET CT scans are identifying early calcification in heart arteries and to use 18F-Fluoride PET CT imaging to gain a deeper insight into the progression of atherosclerosis. It is not feasible to perform detailed examinations of heart arteries in living patients. For this reason post-mortem examination of heart arteries offers a valuable opportunity to correlate PET CT scan findings with biological processes in order to get an understanding of what 'hot spots' on PET/CT scans are actually representing at the tissue level.
This study proposes to explore the biological processes in heart arteries identified with 18F-Fluoride PET CT imaging. Post-mortem hearts of patients both with and without a history of heart disease will be scanned to be able to define what is going on at the gene expression and protein level in the areas of 'hot spots' on CT PET scans.
- Conditions
- Atherosclerosis, Myocardial Infarction, Sudden Cardiac Death
- Medical subject headings
- Atherosclerosis, Myocardial Infarction, Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sudden Cardiac Death Victim with coronary artherosclerosis | Sudden Death victims (>18 years old) who have died in the community and there is supportive evidence of myocardial infarction on autopsy. | |
| Sudden Death Victim without coronary artherosclerosis | Sudden Death victims (>18 years old) who have died in the community with no evidence of coronary atherosclerosis or myocardial infarction on autopsy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
18F-fluoride uptake denotes microcalcification and atherosclerosis in aortic valves and coronary arteries
18F-fluoride uptake denotes microcalcification and atherosclerosis in aortic valves and coronary arteries and the pathways for gene and protein expression that are associated with this remain to be defined and this was assessed by PET/CT imaging
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start9 Nov 2016
- Primary completion9 Nov 2020
- Study completion9 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Weill Medical College of Cornell University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06718465
- Sponsor's protocol ID
- 152959
- Status last verified
- May 2024
- First submitted
- 10 Nov 2014
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Combined Imaging and Informatics Based Approaches to Understanding Cardiovascular Disease.
- ClinicalTrials.gov ID
- NCT06718465
- Acronym / sponsor ID
- 152959
- Conditions
- Atherosclerosis, Myocardial Infarction, Sudden Cardiac Death
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- Weill Medical College of Cornell University
- Study start
- 9 Nov 2016 (actual)
- Primary completion
- 9 Nov 2020 (actual)
- Study completion
- 9 Nov 2020 (actual)
- First posted
- 5 Dec 2024 (actual)
- 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.
Hardening of the arteries (atherosclerosis) is a common disorder that causes heart attacks. In the United Kingdom heart attacks are the commonest cause of death. Combined positron emission tomography (PET) and computer tomography (CT) scans are a new way of assessing atherosclerosis. Using the radiotracer 18F-Fluoride, this study proposes to perform combined PET CT scans on post-mortem hearts from participants with or without a history of heart disease. It will then be able to compare the hot spots found on these scans with what investigators can see under the microscope when looking at heart artery specimens, assess which genes are switched on and proteins present in the hot spots. This will give us an insight into what hot spots on PET CT scans are identifying in areas of atherosclerosis. It will also provide new information relating to the underlying processes that give rise to atherosclerosis and the development of heart attacks. This will pave the way for the future development of new treatments.
Detailed description
Hardening of the arteries (atherosclerosis) is a very common health problem that can lead to fatal or disabling heart attacks or strokes. On many levels, it remains an incompletely understood illness.
Until relatively recently, the only way of assessing the severity of, or risk posed by, atherosclerosis was to measure the degree to which it narrowed a particular blood vessel. This method only tells part of the story; investigators now know that frequently the 'culprit area' of atherosclerosis that causes a heart attack or stroke doesn't necessarily result in narrowing of the blood vessel i.e. if investigators only measure narrowness they will miss lots of 'bad' atherosclerosis.
Combined PET CT scans not only provide more information about the composition and architecture of the atherosclerosis but can provide data about the processes (at the chemical and cellular level) that underlie the disease. Hardened arteries with areas of early calcification (deposits of calcium) are usually the culprits that lead to heart attacks. Early calcification can be detected using 18F-Fluoride PET CT scans. It has previously been described by the Chief Investigator and colleagues that hot spots on 18F-Fluoride PET CT scans are associated with rupture of hardened arteries in stroke patients.
The aim of this study is to explore whether hot spots on 18F-Fluoride PET CT scans are identifying early calcification in heart arteries and to use 18F-Fluoride PET CT imaging to gain a deeper insight into the progression of atherosclerosis. It is not feasible to perform detailed examinations of heart arteries in living patients. For this reason post-mortem examination of heart arteries offers a valuable opportunity to correlate PET CT scan findings with biological processes in order to get an understanding of what 'hot spots' on PET/CT scans are actually representing at the tissue level.
This study proposes to explore the biological processes in heart arteries identified with 18F-Fluoride PET CT imaging. Post-mortem hearts of patients both with and without a history of heart disease will be scanned to be able to define what is going on at the gene expression and protein level in the areas of 'hot spots' on CT PET scans.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sudden Cardiac Death Victim with coronary artherosclerosis | – | –Sudden Death victims (>18 years old) who have died in the community and there is supportive evidence of myocardial infarction on autopsy. |
| Sudden Death Victim without coronary artherosclerosis | – | –Sudden Death victims (>18 years old) who have died in the community with no evidence of coronary atherosclerosis or myocardial infarction on autopsy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include sudden death victims who have died in the community.
Key inclusion criteria (1 listed)
- Sudden death victims dying in the community. Patients with or without a history of ischaemic heart disease.
Key exclusion criteria (1 listed)
- Age under 18 years old. Suspicion around the cause of death, or cases of homicide.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
18F-fluoride uptake denotes microcalcification and atherosclerosis in aortic valves and coronary arteries
Time frame: 2 years
18F-fluoride uptake denotes microcalcification and atherosclerosis in aortic valves and coronary arteries and the pathways for gene and protein expression that are associated with this remain to be defined and this was assessed by PET/CT 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 5 Dec 2024.
Related trials for Atherosclerosis
Recruiting
Effects of Pitavastatin or Combination of Pitavastatin and Ezetimibe on Glucose Metabolism Compared to AtoRvastatin in atheroscLerotic Cardiovascular Disease Patients With Metabolic Syndrome: The EZ-PEARL Randomized Trial
Dyslipidemias, Atherosclerotic Cardiovascular Disease
Recruiting
Pharmacogenomic Informed Statin Prescribing
Hypercholesterolemia
Recruiting
Aggressive Lipid Lowering Therapy in ICI-Treated Melanoma
Melanoma
Not yet recruitingPhase 4
Effectiveness and Tolerability of a Treat-to-Target Versus Fixed-Dose Statin Strategy in Patients With Atherosclerotic Cardiovascular Disease: A Randomized Controlled Trial
Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia, Stroke (CVA) or TIA
Not yet recruitingObservational study
Drug-coated Balloons Versus Drug-eluting Stents for the Treatment of Femoropopliteal In-Stent Restenosis
Femoropopliteal In-Stent Restenosis (ISR)
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis and 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 1 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 5 Dec 2024. 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?
18F-fluoride uptake denotes microcalcification and atherosclerosis in aortic valves and coronary arteries (time frame: 2 years). 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 5 Dec 2024.