Integrated Informatics-imaging Approaches to 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.

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Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Death Death, Sudden Death, Sudden, Cardiac Heart Arrest Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Sudden Cardiac Death Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Sudden death victims dying in the community. Patients with or without a history of ischaemic heart disease.

Exclusion criteria

Age under 18 years old. Suspicion around the cause of death, or cases of homicide.

Treatment and study plan

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Collaborators

Weill Medical College of Cornell University

Registry information

Official study title

Development of Combined Imaging and Informatics Based Approaches to Understanding Cardiovascular Disease.

Important dates

Study start: 2016
Primary completion: 2020
Study completion: 2020
First posted: Dec 5, 2024
Registry last updated: Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed