NCT06804499 Tampere Coronary Artery Disease and Sudden Cardiac Arrest Study
| NCT ID | NCT06804499 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tampere Heart Hospital |
| Condition | Sudden Cardiac Arrest |
| Study Type | OBSERVATIONAL |
| Enrollment | 4,000 participants |
| Start Date | 2025-01-13 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 4,000 participants in total. It began in 2025-01-13 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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In addition to a few short physiological tests (e.g. blood pressure, height, weight, grip strength), a blood sample is withdrawn from a selected group of study subjects.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.
Eligibility Criteria
Inclusion Criteria: 1. Age \> 18 years 2. A patient who lives in the area of 'Wellbeing Services County of Pirkanmaa' and seeks treatment for coronary artery disease (CAD). 3. 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. 4. An invasive coronary angiogram or CTA is done within three (3) months. 5. Good or moderate everyday functional ability Exclusion Criteria: 1. Life expectancy \<1 months. 2. A significant valvular heart disease treated previously (endovascular or surgical) or requires treatment (endovascular or surgical) in the next three (3) months. 3. Previously implanted cardioverter-defibrillators (ICD) or will be implanted in the next three (3) months. 4. An active malignancy (ongoing treatment for a solid tumour, metastatic solid tumour, fast progressing haematological malignancy, or equal malignant disease). 5. 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). 6. Intellectual disability or a significant disability affecting cognitive functions 7. 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.
Contact & Investigator
Jussi Hernesniemi, Professor
✉ jussi.hernesniemi@tuni.fiFrequently Asked Questions
Who can join the NCT06804499 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Sudden Cardiac Arrest. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06804499 currently recruiting?
Yes, NCT06804499 is actively recruiting participants. Contact the research team at jussi.hernesniemi@tuni.fi for enrollment information.
Where is the NCT06804499 trial being conducted?
This trial is being conducted at Tampere, Finland.
Who is sponsoring the NCT06804499 clinical trial?
NCT06804499 is sponsored by Tampere Heart Hospital. The trial plans to enroll 4,000 participants.