An observational study in Sudden Cardiac Arrest, Sudden Cardiac Death and Sudden Cardiac Death Due to Cardiac Arrhythmia, sponsored by Tampere Heart Hospital. Recruiting at 1 site in Finland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Tampere Heart Hospital · Observational
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In addition to a few short physiological tests (e.g. blood pressure, height, weight, grip strength), a blood sample is withdrawn from a selected group of study subjects.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.
Source data verification is not planned for the baseline data acquisition. SCD data is collected from the national death certificate register, which is mandated by Finnish legislation. Death certificates must include information about all the significant prevalent diseases and the events and circumstances leading to death. Also, data regarding the cause of death (ICD-10 classification) and the place of death must be included. The certificate is written by the last physician treating the patient and is complemented with medical or medicolegal autopsy results if available. Research members will fully review all detected SCD case from medical records and death certificates.
Patients treated for CAD in Tampere Heart Hospital are recruited by research staff according to up-to-date Standard Operating Procedures (SOP). Research staff will conduct surveys and physiological measurements and take a blood sample in as planned. The blood sample is processed and stored according to research plan. The collected data is entered and saved to the Tampere Heart Hospital RedCap database. All research staff is trained according to up-to-date SOP. The final analytics of the blood samples including genetic testing will be decided later.
The study is designed to have 80% power (alpha 0.05) to demonstrate a small-medium effect (Cohen's D 0.2-0.5) for normally distributed variables. To this end, 150-200 SCD cases should be detected in the follow-up. Based on previous research, 4000 subjects with four years of follow-up need to be recruited to fulfil the target number of SCD cases. With this sample, a 2.5-3.5 times risk ratio for categorical variables could be detected (80% power).
Missing data will be addressed as such. If significant number of study subjects with missing data will be detected data imputing can be considered during analysis.
Prospective data regarding SCD will be analyzed in addition to conventional statistical methods, with Cox regression model. Also Fine Gray subdistribution models will be used. Machine learning model can used especially analyzing ECG and genetic data.
363 studies on the registry are indexed under Death, Sudden, Cardiac; 84 are open to participants now.
This study's planned enrollment of 4,000 is above the median of 449 across 202 observational studies indexed under Death, Sudden, Cardiac.
Browse Death, Sudden, Cardiac studies →Tampere Heart Hospital is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study will recruit adult patients diagnosed with coronary artery disease (CAD) who are living in the Wellbeing Services County of Pirkanmaa. CAD must be with an invasive coronary angiogram or computed tomography angiogram (CTA), which cardiologists evaluate based on current guidelines for stenosis level evaluation and fractional flow reserve (FFR) results. An invasive coronary angiogram or CTA must be done within three (3) months before recruitment. The study subjects must have a good or moderate everyday functional ability.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Subgroup with blood samples:
Blood samples are withdrawn from all study subjects under 76 years of age. Additionally, PaxGene samples are withdrawn from i) all study subjects under 65 years of age and ii) subjects between 65-76 years, if they have detected QRS-time>110ms in the latest .
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study will recruit adult patients diagnosed with coronary artery disease (CAD) who are living in the Wellbeing Services County of Pirkanmaa. CAD must be with an invasive coronary angiogram or computed tomography angiogram (CTA), which cardiologists evaluate based on current guidelines for stenosis level evaluation and fractional flow reserve (FFR) results. An invasive coronary angiogram or CTA must be done within three (3) months before recruitment. The study subjects must have a good or moderate everyday functional ability. The study is non-interventional.
Sudden Cardiac Death (SCD)
The primary endpoints of the study are sudden cardiac death (SCD) and sudden cardiac arrest (SCA). A SCD is defined as: * a cardiac death within one hour from the beginning of symptoms, * or if the patient is found dead (cardiac causes) but is known to have a good clinical condition within 24 hours and A SCA is defined as: * a hemodynamical collapse by cardiac cause and not influenced by trauma, drowning, respiratory insufficiency, drug overdose, or other non-cardiac cause. * There are no limitations on symptom duration.
Time frame: 15 years
Secondary endpoints
Secondary endpoint include significant cardiovascular diseases, like detected strokes, myocardial infarctions, revascularization procedures, arrythmias (eg atrial fibrillation).
Time frame: 15 years
Treatment compliance and secondary treatment targets
Secondary endpoints include significant cardiovascular diseases, like detected strokes, myocardial infarctions, revascularization procedures, and arrhythmia (e.g. atrial fibrillation). Treatment compliance is monitored based on drug purchases and achieving clinically set secondary prevention targets (e.g., cholesterol levels, blood pressure, and blood glucose levels).
Time frame: 15 years
Plan to share: Undecided — IPD can be only shared according to European General Data Protection Regulation (GDPR) and other regulation as appropriate.
No publications or documents are linked to this record.
Started Jan 2025 (actual). Primary completion is estimated for Dec 2027, 35 months after the start.
Of 69 non-industry observational studies under Death, Sudden, Cardiac, half reached primary completion within 74 months of starting (the median), counting those still running; a quarter within 42. This study's planned 35 months is below that.
Counting every sponsor, half of 85 studies reached it within 63 months; a quarter within 40.
How these figures are worked out, and which studies are left out of them.
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Tampere Heart Hospital