CompletedNot Applicable

Novel Imaging Approaches To Identify Unstable Coronary Plaques

United Kingdom80 participantsStarted 2012-02

Plain-language summary

Cardiovascular disease is the leading cause of death in Scotland and the Western World. Approaches to improve the identification of vulnerable or ruptured coronary atherosclerotic plaques are urgently needed to help risk stratification, to identify patients for intensive therapies, and to provide novel biomarkers for the development of anti-atherosclerotic drug interventions. Using positron emission tomography, we have recently shown that sodium 18-fluoride uptake holds major promise as a novel marker of plaque vulnerability and rupture. Here we wish to characterise coronary atherosclerotic plaque using 128-multidetector computed tomography combined with 18-fluorodeoxyglucose and sodium 18-fluoride positron emission tomography and Virtual histology-intravascular ultrasound in 80 patients with stable and unstable coronary artery disease. This has the potential to provide an innovative and highly valuable translational model with which to test novel therapeutic interventions targeted at reducing atheroma and plaque rupture. This could have major implications for the future treatment of cardiovascular disease.

Who can participate

Age range

50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Age \> or = 50 yrs. Patients with Acute coronary syndromes or stable coronary artery disease. Exclusion Criteria: Insulin dependent diabetes Inability or unwillingness to undergo computed tomography scanning Severe renal failure (serum creatinine \>250 µmol/L or estimated glomerular filtration rate \<30 mL/min) Known contrast allergy Inability to give informed consent. Females in child bearing age will undergo pregnancy test if pregnancy suspected. Participation in other research studies requiring exposure to further radiation (over and above mentioned in this study).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Patients with ACS have focal 18F-NaF uptake and high tissue to background ratio(TBR) and standardised uptake values (SUV) in the culprit vessels.

Timeframe: Within 1 month of index event

What are the morphological characteristics of plaque with high 18F-NaF tissue to background ratio or standardised uptake value

Timeframe: 1 month

Trial details

NCT IDNCT01749254

SponsorUniversity of Edinburgh

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2015-04

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