FAQ
What is the SwissCardIA study?
SwissCardIA is a cardiovascular health research study involving 2’000 people aged 50 to 69 in the cantons of Vaud and Geneva.
It aims to better understand the early and silent stages of atherosclerosis, meaning the gradual accumulation of plaques in the arteries.
Why is this study important?
Many people who go on to develop cardiovascular disease feel completely healthy beforehand. Today, it is still difficult to know who will remain healthy and who may develop problems later.
SwissCardIA aims to better understand these differences, so that prevention can become more precise and better adapted to each person.
Who organizes and conducts this study?
The study is initiated and conducted by Lausanne University Hospital (Centre Hospitalier Universitaire Vaudois, CHUV) in collaboration with Geneva University Hospitals (Hôpitaux Universitaires de Genève, HUG) and the Swiss Federal Institute of Technology Lausanne (École Polytechnique Fédérale de Lausanne, EPFL).
CHUV is the sponsor of the study, meaning that it has overall responsibility for the study. It oversees its conduct and ensures that the project is carried out in accordance with the approved protocol, applicable ethical and legal requirements, and standards for participant safety and data protection.
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The researchers involved in SwissCardIA are clinicians, scientists, and healthcare professionals from CHUV, HUG, and EPFL, who work together to address the study’s scientific questions.
Who can participate in the study?
Participation is intended for people who are:
- aged 50 to 69;
- residents of the canton of Vaud or Geneva;
- not known to have heart disease;
- not taking cholesterol-lowering treatment;
- meeting the other medical inclusion and exclusion criteria of the study.
Final eligibility is verified by the research team.
How are participants selected?
The people invited to participate in the SwissCardIA cohort study were randomly selected from the cantonal register by the Federal Statistical Office. This procedure was authorized by the competent ethics authorities (CER-VD, CCER).
Only the name, address and age required to send the invitation were provided to CHUV. No other personal or medical information was communicated.
Can I register voluntarily?
No, participation in the study is limited to people selected at random. This ensures the final sample of selected participants to be representative of the studied population.
I was contacted to participate in the study but I do not wish to participate. What happens?
If you do not respond, a reminder letter may be sent to you. If you do not respond after this reminder, you will receive no further communication concerning the study. The contact details used to contact you will be permanently deleted once recruitment is complete.
What does participation involve?
Participation lasts approximately four years and includes up to four visits at CHUV or HUG, as well as three annual telephone interviews.
The main stages are as follows:
- Visit 1: measurements of weight, height and blood pressure, ECG, fasting blood draw, questionnaires and provision of a smartwatch to be worn for three months;
- Visit 2, three months later: return of the watch and CT scan of the coronary arteries;
- Follow-up: one telephone interview per year for approximately three years;
- Visits 3 and 4: repetition of certain measurements, questionnaires, smartwatch and a new CT scan, depending on the participant’s eligibility.
Optional examinations may also be offered, including a digital food diary, cardiac MRI, carotid ultrasound, sleep recording and analysis of the gut flora.
I am a participant. What are my rights and obligations?
As a participant, you have the right:
- to ask questions at any time;
- to access your data;
- to withdraw from the study at any time, without having to provide a reason and without any adverse consequences for your care;
- to be informed of clinically relevant results and incidental findings that are important for your health.
By participating, you agree in particular to follow the study instructions, attend certain visits while fasting, wear the smartwatch as planned, return the loaned equipment and inform the research team of important changes concerning your health or treatments.
If you withdraw your participation in the study, your data and samples already collected may continue to be analyzed in coded form as part of the project.
Are there risks associated with participation?
Participation involves minor risks and constraints:
- a blood draw may cause pain, bruising or local irritation;
- the CT scan exposes you to a low dose of X-rays and requires the administration of an iodinated contrast agent, which may cause rare allergic reactions or temporarily affect the kidneys;
- the medications used during the CT scan may cause dizziness, a drop in blood pressure, headaches or a feeling of warmth;
- some optional examinations, particularly cardiac MRI, also have contraindications and rare risks related to medications or the contrast agent;
- the questionnaires may be long and address personal subjects;
- despite the security measures in place, a very low residual risk concerning data confidentiality remains.
The medical team will check for any contraindications and provide the necessary monitoring during the examinations.
What data are collected?
The study collects the following data types:
- demographic and socioeconomic information;
- information on health, medical history and treatments;
- data on physical activity, sleep, diet, smoking and mental health;
- physical measurements, such as weight, height and blood pressure;
- data from the ECG, blood tests and medical imaging;
- lifestyle (sleep, physical activity, heart rate) data recorded by a smartwatch;
- genomic data obtained from DNA analysis;
- for people who consent to undergo optional examinations, additional information on dietary patterns, sleeping habits, gut microbiota composition, as well as additional cardiovascular imaging data will be collected.
How are data protected?
All study data are coded: information that can identify you, such as your name or date of birth, is replaced by a code. The list linking this code to your identity is stored in a secure file at a separate location within the hospital.
Data generated by wearables, such as the smartwatch and the digital food diary, are also transmitted and stored in coded form on secure servers.
Only a limited number of people can access uncoded information, and only when this is necessary for the conduct of the study. These people are bound by professional secrecy.
Who has access to study data?
Authorized members of the team responsible for organizing the visits may access information that can identify participants when necessary.
Researchers who analyze the data normally have access only to coded data. Some coded data may also be transferred to scientific or technical partners in Switzerland or abroad, without transferring name or contact details from participants.
The ethics committees who authorized the study, as well as the people responsible for monitoring the project, may also review certain data during inspections. They are bound by professional secrecy.
How long are data retained?
Study data are retained for the complete duration of the study, meaning until the completion of all analyses.
Participants can also consent to the future reuse of their genomic data and biological material, beyond the analyses planned within the frame of SwissCardIA. This means that their data will be retained in coded form for an indefinite period, as long as consent is not withdrawn, in a biobank.
The contact details obtained from the Federal Statistical Office and used only for the invitation will be permanently deleted once recruitment is complete.
I am a participant. Will I receive the results of the examinations performed as part of the study?
You will receive the standardized results of your blood tests and CT scans. However, the results of exploratory analyses performed solely for research purposes, including certain genomic analyses, will not be communicated to you individually.
The study is not intended to provide a complete medical assessment or personalized care. Your treating physician will remain your main contact for interpreting the results and deciding whether follow-up is required.
I am a participant. Will my doctor be informed?
The results of your blood tests and CT scans may be sent to your general practitioner if you agree and provide their contact details to the research team.
You can indicate in the consent form whether or not you authorize this transmission.
I am a participant. What happens if an important finding is made?
If an important medical result or incidental finding that may affect your health is identified, you will be informed orally and in writing.
With your agreement, this information may also be sent to your general practitioner so that appropriate follow-up can be arranged. Depending on the finding, the team may recommend a consultation or refer you to a specialized department.
Some findings may also lead to your participation being stopped or adapted. For example, advanced kidney failure would prevent the CT scan with contrast agent from being performed.
Where do the visits take place?
Data collection is conducted in Switzerland at two sites:
- at CHUV in Lausanne
- at HUG in Geneva.
Data analysis is conducted at all three partnering institutions: CHUV, HUG, and EPFL.
Is participation in the study paid?
Compensation is provided for the time devoted to the study and any travel expenses:
- CHF 50.- for Visit 1
- CHF 75.- for Visit 2
- CHF 75.- for Visit 3
- CHF 100.- for Visit 4
- an additional CHF 25.- for each optional examination performed.
The total compensation cannot exceed CHF 550.-
Participation does not result in any costs for you or your health insurance. However, medical examinations or treatments performed outside the study following a result are subject to the usual conditions of your insurance.
I am a participant. Who should I contact if I have a question?
The contact details of your recruiting center have been communicated to you directly via mail or e-mail.
In case of doubt, or if you have any questions, you can contact the study team by email at info@swisscardia.ch.
What happens to the study results?
The data collected will be analyzed to better understand the factors associated with the development and progression of atherosclerosis. They will be used in particular to develop new cardiovascular risk prediction models, including with artificial intelligence methods.
The results may be presented at conferences or published in scientific journals. They will be communicated in a form that does not allow participants to be identified.
A summary of the overall results will be sent to participants at the end of the project.
When will the results be available?
Individual participation lasts four years, while the overall project is expected to run for approximately seven years. A summary of the overall study results will be shared at the end of the project.
All scientific publications related to the project are listed on the Publications page of the website.
How is this study funded?
The project is currently funded mainly through a private donation managed by the Fondation vaudoise de cardiologie, and allocated to the CHUV Department of Cardiology specifically for the conduct of SwissCardIA.