OptimiZation Of lipid lowering therapies using a DSS in ACS - ZODIAC
Research type
Research Study
Full title
Implementation of a Decision Support System and its effect on early optimisation of Lipid-Lowering Therapies in patients with Acute Coronary Syndrome: a cluster Randomised Controlled Trial
IRAS ID
317589
Contact name
Kausik K Ray
Contact email
Sponsor organisation
Imperial College London
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 2 months, 29 days
Research summary
Summary of Research
Clinicians should prescribe appropriate treatments for Atherosclerotic Cardiovascular Disease (ASCVD) in accordance with expert guidelines, yet in current practice Lipid Lowering Therapies (LLTs) are often initiated later and with less potent single or combination therapies than recommended.
Imperial College London has developed a Decision Support System (DSS) which – after inputting various patient values - visualises the projected cardiovascular (CV) disease risk with single or combination therapies over time for adults (aged 18 - 80 years) with Acute Coronary Syndrome (ACS) who have recently been hospitalised (within 72 hours).
The study aims to assess whether the availability of the DSS compared to routine care alone results in an increased initiation or intensification of combination LLTs over a 24-week period after an ACS event.
This will be a cluster randomised trial with a total of 48 secondary care sites randomised to Standard of Care (SoC) [24 sites] or DSS [24 sites] across 3 countries: the United Kingdom (UK), Spain and Italy. There will be 16 sites per country; 8 DSS sites; 8 SoC sites. DSS sites will receive a standardised period of training prior to commencing patient recruitment. Participants will be followed up for a minimum of 24 weeks. Following the use of the DSS and regardless of its use, it is ultimately up to the clinical users to choose and prescribe a suitable therapy for their patients based on their clinical knowledge.Summary of Results
ZODIAC lay summary of results
Short Title:
OptimiZation Of lipid lowering therapies using a Decision support system In patients with Acute Coronary syndrome – the ZODIAC trial.
Who carried out the research?
The Sponsor of the ZODIAC trial is Imperial College London.
The Funder is Sanofi Winthrop Industrie.Study purpose:
Acute coronary syndrome happens when blood flow to a person’s heart suddenly reduces or stops, often causing a heart attack. This is normally because cholesterol, a fatty substance in the blood, builds up over time. Smoking, diabetes, and high blood pressure can make this more likely.
After someone has had a heart attack, the chance of having another one is higher. That is why lowering cholesterol is very important, even if a person’s cholesterol levels look ‘normal.’ Medicines can help lower cholesterol and keep the heart healthier. But adding medicines one at a time may mean it takes longer to reach the best cholesterol level.
Imperial College London developed a special website called a Decision Support System (DSS). The DSS works by showing the benefits of all the different medicines which help lower the chance of another heart attack for each person.
The ZODIAC trial tested the DSS website in 42 hospitals across the UK, Italy, and Spain. Hospitals were split into two groups at random, like tossing a coin. One group used the DSS, while the other group did not use the DSS and gave care in the usual way. The doctors and nurses using the DSS were shown how to use it.
People taking part:
• The trial included adults between 18 and 79 years old.
• People could take part if they were in hospital and had a heart attack in the past 3 days.
• ZODIAC collected data after a heart attack (this was the Baseline Visit), and again during 16 weeks (the Follow Up period).
• 17 UK hospitals took part, 8 hospitals used the DSS and 9 hospitals did not use the DSS.
• 534 people took part throughout the UK.
• 1,139 people took part in total.Results:
• Most people in the trial were men (79%).
• The most common age was 61 years old.
• Nearly 1 in 5 people (20%) had diabetes when they had a heart attack.
• About 1 in 3 people (35%) smoked regularly.
• The results showed that the DSS seemed to help doctors choose better treatments, but the difference between groups was too small to be sure.
• ZODIAC needed more people to take part in order to show a difference between the two groups.
• At the end, doctors and nurses who used the DSS were asked to complete a survey about it.
• Most doctors and nurses who used the DSS said it was easy to use (81%) and that they would like to use it more often (71%).Conclusions:
Bigger studies are needed in future to find out if the DSS can make a difference in hospitals and GP practices.
Even though the results did not show a difference, doctors and nurses found the DSS useful and easy to use.
Public Involvement:
Before ZODIAC started:
Patients who have heart problems were given the participant information sheet to read to make sure the wording was clear and easy to understand.
After ZODIAC finished:
A group of 9 volunteers (who were not part of ZODIAC) helped review a video draft that explained the trial and a summary of the results. They made several suggestions on how it looked and how it could be changed to make it easier to understand.
We thank all our volunteers for their help.
Where can I learn more about this trial?
The trial results have been published here: https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fdoi.org%252F10.1093%252Fehjdh%252Fztaf135%2FNBTI%2F8xPCAQ%2FAQ%2Fb6b6f8be-b1fe-4b31-9428-ed0e7fb6f78b%2F2%2FDcoG5-22Sq&data=05%7C02%7Capprovals%40hra.nhs.uk%7C3dcd95d93dd54cfa8ea208de3ca3f560%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C639014872074780001%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=DuCEbJx45wbd0zDRo0BabW0TYcCtAxcwu2dPsYw5%2FaA%3D&reserved=0
ZODIAC is registered on the following public database: Study Details | NCT05844566 | OptimiZation Of Lipid Lowering Therapies Using a Decision Support System In Patients With Acute Coronary Syndrome. | ClinicalTrials.gov
ZODIAC animation: https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fvimeo.com%252F1056330384%252Fb965ca0d37%253Fts%253D0%2526share%253Dcopy%2FNBTI%2F8xPCAQ%2FAQ%2Fb6b6f8be-b1fe-4b31-9428-ed0e7fb6f78b%2F3%2FAYOH30SqPS&data=05%7C02%7Capprovals%40hra.nhs.uk%7C3dcd95d93dd54cfa8ea208de3ca3f560%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C639014872074800885%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=k9LwAMa%2FCQ1MHrrLcuqSzkw%2BjwauIskEfNcTexPUUTI%3D&reserved=0
The ZODIAC researchers would like to say a big thank you to everyone who participated in ZODIAC
REC name
South East Scotland REC 02
REC reference
22/SS/0106
Date of REC Opinion
19 Dec 2022
REC opinion
Favourable Opinion