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This registry is a large-scale epidemiological study (PREVASC) aimed at estimating the prevalence of symptomatic and asymptomatic valvular hear disease in men and women aged over 65 years randomly selected in Italy.
PREVASC is a cross-sectional, population-based study. Participating subjects are invited from the general population and underwent a physical examination and an electrocardiography and echocardiographic examination by a local cardiologist. A random sample of about 2000 subjects over 65 years will be considered for sampling. The sample size is determined on the basis of a priori criteria in order to estimate a prevalence of 3% [standard error (SE) ± 1.1] for VHD.
Both clinical and demographic information will be collected to better characterize the invited population. Written informed consent for the clinical examination will be asked.
Demographic variables, cardiovascular (CV) risk, clinical history, physical findings, and medications will be recorded in a Case Report Form (CRF) by physicians or trained nurses. Assessment of anthropometric measures, blood pressure, and heart rate will be performed according to MONICA recommendations. Overweight is defined as a body mass index (BMI) between 25 and 29.9 kg/m2. Obesity is defined as BMI ≥30 kg/m2. Symptoms and signs attributable to VHD will be evaluated and reported on the CRF by a dedicated expert physician in each site at the time of the physical examination.
Echocardiography Complete Colour Doppler echocardiography will be performed in peripheral centers using commercially available machines according to a pre-defined protocol. Echocardiograms will be recorded in standard DICOM format on digital.
The following parameters will be acquired:
Cardiologists and nurses will be trained locally according to standardized methodologies. Before enrolment begins, all participating centers will be required to perform and send an echo test to the Core Lab to verify the appropriateness of the acquisition procedure.
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| Measure | Description | Time Frame |
|---|---|---|
| VALVOLAR HEART DISEASE PREVALENCE | The aim is to estimate the prevalence of symptomatic and asymptomatic valvolar heart disease in men and women aged over 65 years randomly selected in Italy: a complete colour-Doppler echocardiography will be performed in peripheral centres using commercially available machines according to a pre-defined protocol. Echocardiograms will be recorded with standard DICOM format on digital | at baseline |
| Measure | Description | Time Frame |
|---|---|---|
| LEFT VENTRICOLAR DIMENSIONS AND FUNCTION | The aim is to estimate the prevalence of symptomatic and asymptomatic valvular heart disease in men and women aged over 65 years randomly selected in Italy: complete colour-Doppler echocardiography will be performed in peripheral centers using commercially available machines according to a pre-defined protocol. Echocardiograms will be recorded in standard DICOM format on digital |
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Inclusion Criteria:
Exclusion Criteria:
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Subject with > 65 years with no history of previous valvular heart disease living in villages with less than 3000 inhabitants.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nazario NC Carrabba, phisician | Contact | 00393355939482 | carrabban@aou-careggi.toscana.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AOUCareggi | Recruiting | Florence | 50134 | Italy |
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| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D001024 | Aortic Valve Stenosis |
| D001022 | Aortic Valve Insufficiency |
| D014262 | Tricuspid Valve Insufficiency |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000082862 | Aortic Valve Disease |
| D014694 | Ventricular Outflow Obstruction |
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| at baseline |
| BURDEN OF ATRIAL FIBRILLATION | The aim is to assess the burden of atrial fibrillation: a 12-lead electrocardiogram is performed to all patients enrolled | baseline |