Tampere Coronary Artery Disease and Sudden Cardiac Arrest Study (NCT06804499) | Clinical Trial Compass
RecruitingNot Applicable
Tampere Coronary Artery Disease and Sudden Cardiac Arrest Study
Finland4,000 participantsStarted 2025-01-13
Plain-language summary
The goal of this observational study is to recognize clinical and genetic risk factors for sudden cardiac arrest (SCA) and death (SCD) in patients with coronary artery disease (CAD).
The main questions it aims to answer are:
Are we able to recognize clinical or treatment-related risk factors for SCA or SCD? Can we identify new genetic risk factors for SCA or SCD in patients under 75 years?
Participants diagnosed with CAD answer a short survey about their medical history and socioeconomic status. A standard ECG addition to a five (5) minute ECG recording is taken from all the study subjects. In addition to a few short physiological tests (e.g. blood pressure, height, weight, grip strength), a blood sample is withdrawn from a selected group of study subjects.
Medical healthcare records are used to follow all study subjects, and no follow-up visits are required.
Who can participate
Age range
18 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 \> 18 years
. A patient who lives in the area of 'Wellbeing Services County of Pirkanmaa' and seeks treatment for coronary artery disease (CAD).
. CAD is diagnosed with invasive coronary angiogram or computed tomography angiogram (CTA) which is evaluated by cardiologists based on current guidelines for stenosis level evaluation and fractional flow reserve (FFR) results.
. An invasive coronary angiogram or CTA is done within three (3) months.
. Good or moderate everyday functional ability
Exclusion criteria
. Life expectancy \<1 months.
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.
. A significant valvular heart disease treated previously (endovascular or surgical) or requires treatment (endovascular or surgical) in the next three (3) months.
. Previously implanted cardioverter-defibrillators (ICD) or will be implanted in the next three (3) months.
. An active malignancy (ongoing treatment for a solid tumour, metastatic solid tumour, fast progressing haematological malignancy, or equal malignant disease).
. A significant neurodegenerative disease (dementia, Mini-Mental State Examination (MMSE) \<23 or equivalenneurodegenerative disease affecting everyday functional ability, like ALS, myositis, prograded MS-disease or Parkinson's disease).
. Intellectual disability or a significant disability affecting cognitive functions