Tampere Coronary Artery Disease and Sudden Cardiac Arrest Study

NCT06804499 | Recruiting DMC

• 1 other identifier: R24037
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

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In addition to a few short physiological tests (e.g. blood pressure, height, weight, grip strength), a blood sample is withdrawn from a selected group of study subjects.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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  15 years

Secondary Outcomes (1)

• Secondary endpoints

  15 years

Other Outcomes (1)

• Treatment compliance and secondary treatment targets

  15 years

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Tampere Heart Hospital: lead
• Tampere University: collaborator
• Tampere University Hospital: collaborator

Study Sites (1)

Tampere University Hospital Tampere Heart Centre

Tampere, Pirkanmaa, 33100, Finland

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Death, Sudden, Cardiac; Coronary Artery Disease; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Jussi Hernesniemi, Professor

CONTACT

jussi.hernesniemi@tuni.fi

Juho Tynkkynen, Medical Doctor, Phd

CONTACT

+358 3 311 611; juho.tynkkynen@pirha.fi

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 15 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Director

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: February 3, 2025
• Study Start: January 13, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2042
• Last Updated: February 3, 2025

Record last verified: 2025-01

Locations

FI (1)