Sudden Cardiac ArrestCADSCANCT06804499
Tampere Coronary Artery Disease and Sudden Cardiac Arrest Study
An observational study of Sudden Cardiac Arrest and Sudden Cardiac Death, run by Tampere Heart Hospital at 1 site in Finland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sudden Cardiac Arrest, Sudden Cardiac Death, Sudden Cardiac Death Due to Cardiac Arrhythmia
- How many people
- 4,000 participants
- Where
- 1 siteFinland
- Study dates
- 13 Jan 2025to 31 Dec 2042
- How long will I take part?
- 15 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- Life expectancy <1 months.
- 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
Show all 9Show fewer
- Do-not-resuscitate (DNR) treatment decision
- 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 ECG.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jussi Hernesniemi, Professor contact
Finland1 site, 1 recruiting
- Recruiting
Tampere University Hospital Tampere Heart Centre
Tampere, Pirkanmaa, 33100
Kati Helleharju, Research cordinator, +358 3 311 611, kati.helleharju@sydansairaala.fi
About this study
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:
Read more
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.
Read the detailed description
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.
- Conditions
- Sudden Cardiac Arrest, Sudden Cardiac Death, Sudden Cardiac Death Due to Cardiac Arrhythmia, Coronary Arterial Disease (CAD), Acute Coronary Event
- Keywords
- sudden cardiac death, sudden cardiac arrest, coronary artery disease, acute coronary syndrome
- Medical subject headings
- Death, Sudden, Cardiac, Coronary Artery Disease, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Coronary Artery Disease | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 years
Secondary outcomes (1)
Secondary endpoints
Secondary endpoint include significant cardiovascular diseases, like detected strokes, myocardial infarctions, revascularization procedures, arrythmias (eg atrial fibrillation).
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start13 Jan 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2042 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sudden Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
- Target duration
- 15 Years
Sponsor and investigators
- Lead sponsor
- Tampere Heart Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University, Tampere University Hospital
- Responsible party
- Principal investigator, Jussi Hernesniemi, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06804499
- Sponsor's protocol ID
- R24037
- Acronym
- CADSCA
- Status last verified
- Aug 2026
- First submitted
- 14 Jan 2025
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD can be only shared according to European General Data Protection Regulation (GDPR) and other regulation as appropriate.
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tampere Coronary Artery Disease and Sudden Cardiac Arrest Study
- ClinicalTrials.gov ID
- NCT06804499
- Acronym / sponsor ID
- CADSCA / R24037
- Conditions
- Sudden Cardiac Arrest, Sudden Cardiac Death, Sudden Cardiac Death Due to Cardiac Arrhythmia, Coronary Arterial Disease (CAD), Acute Coronary Event
- Keywords
- sudden cardiac death, sudden cardiac arrest, coronary artery disease, acute coronary syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Tampere Heart HospitalUniversity, hospital or other
- Collaborators
- Tampere University, Tampere University Hospital
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2042 (estimated)
- First posted
- 3 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Coronary Artery Disease | – | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- Life expectancy <1 months.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sudden Cardiac Death (SCD)
Time frame: 15 years
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.
1 secondary outcome
Secondary endpoints
Time frame: 15 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: Undecided. IPD can be only shared according to European General Data Protection Regulation (GDPR) and other regulation as appropriate.
Related trials for Sudden Cardiac Arrest
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
RecruitingObservational study
Genetic Markers of Cardiovascular Disease in Epilepsy
Epilepsy, Seizures
RecruitingObservational study
Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
Chronic Lymphocytic Leukemia (CLL), Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia
Not yet recruitingObservational study
Cardiovascular Pre-participation Screening in Children and Adolescents
Sudden Cardiac Death, Cardiac Arrhythmias
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jussi Hernesniemi, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sudden Cardiac Arrest and Sudden Cardiac Death, run by Tampere Heart Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jussi Hernesniemi, Professor (jussi.hernesniemi@tuni.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sudden Cardiac Death (SCD) (time frame: 15 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.