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Clinical Trial Summary

This is a prospective cohort study continuously measuring all forms of arrhythmias, sleep apnea during sleeping hours and physical activity using sensors in modern implanted pacemakers. These measures will be correlated with the incidence of common co-morbidities such as arterial hypertension, coronary artery disease, heart failure, COPD, peripheral artery disease, iron insufficiency. In a long follow up perspective major adverse cardiovascular events will be recorded and new risk scores will be developed, incorporating machine learning techniques.


Clinical Trial Description

ACaSA will provide detailed information on night-time SDB and its variability, daily activity levels and different forms of arrhythmias such as atrial fibrillation, premature extra beats and other ECG measures. These data will be correlated with different forms of subclinical coronary atherosclerosis, including calcification score (Agatston-Score: stratified to 0, 1-10, 11-100, 101-400, >400). Coronary lesions will be graded according to the CADSRAD classification (minimal < 10%, mild < 50%, moderate 50-70%, severe > 70%). Coronary plaques will be classified as T1 = calcified, T2 = mixed, T3 = mixed, primarily calcified, T4 = non-calcified). "High risk plaque"-criteria will include: low attenuation plaque, napkin-ring, spotty calcification < 3mm, remodelling index. In addition, lung function testing will add information about concomitant COPD, asthma and overlap-syndromes, which will be correlated to above mentioned measures as well. The most prevalent co-morbidity is expected to be arterial hypertension. Therefore, its diagnosis based on ambulatory 24-hours measurement (ABPM) and possible end organ damages such as left ventricular hypertrophy will be part of the baseline assessment as well. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05127720
Study type Observational [Patient Registry]
Source Medical University Innsbruck
Contact
Status Not yet recruiting
Phase
Start date November 30, 2021
Completion date November 30, 2032

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