Tampere Coronary Artery Disease and Sudden Cardiac Arrest Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTampere Heart Hospital

About this trial

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In addition to a few short physiological tests (e.g. blood pressure, height, weight, grip strength), a blood sample is withdrawn from a selected group of study subjects.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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

4,000 Participants
are grouped into 1 trial group
Group A: Patients with Coronary Artery Disease

Trial outcomes

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.

Time frame
15 years

Secondary outcomes

1

Secondary endpoints

Secondary endpoint include significant cardiovascular diseases, like detected strokes, myocardial infarctions, revascularization procedures, arrythmias (eg atrial fibrillation).

Time frame
15 years

Other outcomes

1

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tampere Heart Hospital

Lead sponsor

Tampere University Hospital

Sponsor institution

Tampere University

Collaborator

Tampere University Hospital

Collaborator