Identifying risk factors for sudden cardiac arrest in coronary artery disease patients

Tampere Coronary Artery Disease and Sudden Cardiac Arrest Study

This study is trying to find out what clinical and genetic factors might increase the risk of sudden cardiac arrest in people with coronary artery disease.

Quick facts

• Study type: Observational
• Enrollment: 4000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Tampere Heart Hospital (Academic / other)
• Locations: 1 site (Tampere, Pirkanmaa)
• Trial ID: NCT06804499 on ClinicalTrials.gov

What this trial studies

This observational study aims to identify clinical and genetic risk factors associated with sudden cardiac arrest (SCA) and sudden cardiac death (SCD) in patients diagnosed with coronary artery disease (CAD). Participants will complete a survey regarding their medical history and socioeconomic status, undergo standard ECG recordings, and have physiological measurements taken. Blood samples will also be collected from a subset of participants for future genetic analysis. The study will utilize national death certificate data to track SCD cases and analyze the collected information to better understand risk factors.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old diagnosed with coronary artery disease who live in the Wellbeing Services County of Pirkanmaa.

Not a fit: Patients with a life expectancy of less than one month or those with significant valvular heart disease or active malignancies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved identification of at-risk patients and potentially enhance prevention strategies for sudden cardiac events.

How similar studies have performed: Other studies have shown success in identifying risk factors for sudden cardiac events in similar populations, suggesting this approach may yield valuable insights.

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.

Where this trial is running

Tampere, Pirkanmaa

• Tampere University Hospital Tampere Heart Centre — Tampere, Pirkanmaa, Finland (Recruiting)

Study contacts

• Study coordinator: Jussi Hernesniemi, Professor

Conditions Sudden Cardiac Arrest; Sudden Cardiac Death; Sudden Cardiac Death Due to Cardiac Arrhythmia; Coronary Arterial Disease; Acute Coronary Event; sudden cardiac death; sudden cardiac arrest; coronary artery disease