Ignite Creation Date:
2024-05-06 @ 7:06 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05892588
Status:
RECRUITING
Last Update Posted:
2023-06-07
First Post:
2023-05-25
Brief Title:
Prevalence Study of Cardiovascular Diseases in a Population 65 Years in Italy
Sponsor:
Azienda Ospedaliero-Universitaria Careggi
Organization:
Azienda Ospedaliero-Universitaria Careggi
Study Overview
Official Title:
Prevalence Study of Cardiovascular Diseases in a Population 65 Years in Italy
Status:
RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PREVASC
Brief Summary:
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
Detailed Description:
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 11 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 299 kgm2 Obesity is defined as BMI 30 kgm2 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
Linear measurements of cardiac chambers will be obtained from the two-dimensional 2D parasternal long axis view or when available from the M-mode parasternal short axis recording according to the recommendations of the European American Society of Echocardiography and the European Association of Cardiovascular Imaging
LV volumes will be obtained from the apical four-chamber view and the EF calculated by using the modified Simpsons rule method
Left ventricular mass will be calculated according to the Devereux formula
Left ventricular systolic function will be calculated using the formula for ejection fraction EF EDV-ESVEDV X100
Also left atrium area or volume will be measured by the 4-chamber view
Calcifications of the aortic valve and mitral apparatus will be quantified as light moderate or severe according to a published approach The bicuspid aortic valve will be searched for and recorded Trans-aortic and trans-mitral gradients as well as mitral aortic and tricuspid regurgitation will be reported and quantified according to continuous wave Doppler and Color Doppler area of regurgitation or vena contracta VC width light moderate severe respectively For quantitative measurement of mitral regurgitation and tricuspidal regurgitation PISA method will be used For aortic regurgitation PHT will be adopted other than VC The aortic valve area will be calculated using the continuity equation other than the planimetric area Mitral valve area will be calculated using pressure half time PHT other than planimetric area Pulmonary artery systolic pressure will be estimated according to standard method
Doppler-derived indexes of transmitral flow and pulmonary vein flow and tissue Doppler imaging of the lateral mitral annulus Ee will be used to define diastolic LVD Peak early diastolic filling wave E velocity peak atrial diastolic filling wave A velocity and deceleration time of the E wave DTE will be measured at the tips of the mitral leaflets The DTE will be calculated as the time from E to the time when the descent of E intercepts the zero line The duration of the transmitral A wave velocity will also be measured The peak velocity of pulmonary venous PV systolic S and diastolic D flow the peak velocity of PV backward flow at atrial contraction PVa and the PVa wave duration PVa dur will be measured with the sample volume placed in the right upper pulmonary vein in the four-chamber axis view The difference between the transmitral A wave duration Adur and PVa dur will be derived as an indirect index of increased LV filling pressures according to the standard method Tissue Doppler will be used to calculate the Ee ratio
All digital echocardiograms will be analyzed offline on a dedicated workstation by three independent observers blind to clinical data and reviewed by the same experienced reader Measurements will be expressed as an average of three cycles in sinus rhythm and from three to five cycles in atrial fibrillation
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
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 299 kgm2 Obesity is defined as BMI 30 kgm2 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
Linear measurements of cardiac chambers will be obtained from the two-dimensional 2D parasternal long axis view or when available from the M-mode parasternal short axis recording according to the recommendations of the European American Society of Echocardiography and the European Association of Cardiovascular Imaging
LV volumes will be obtained from the apical four-chamber view and the EF calculated by using the modified Simpsons rule method
Left ventricular mass will be calculated according to the Devereux formula
Left ventricular systolic function will be calculated using the formula for ejection fraction EF EDV-ESVEDV X100
Also left atrium area or volume will be measured by the 4-chamber view
Calcifications of the aortic valve and mitral apparatus will be quantified as light moderate or severe according to a published approach The bicuspid aortic valve will be searched for and recorded Trans-aortic and trans-mitral gradients as well as mitral aortic and tricuspid regurgitation will be reported and quantified according to continuous wave Doppler and Color Doppler area of regurgitation or vena contracta VC width light moderate severe respectively For quantitative measurement of mitral regurgitation and tricuspidal regurgitation PISA method will be used For aortic regurgitation PHT will be adopted other than VC The aortic valve area will be calculated using the continuity equation other than the planimetric area Mitral valve area will be calculated using pressure half time PHT other than planimetric area Pulmonary artery systolic pressure will be estimated according to standard method
Doppler-derived indexes of transmitral flow and pulmonary vein flow and tissue Doppler imaging of the lateral mitral annulus Ee will be used to define diastolic LVD Peak early diastolic filling wave E velocity peak atrial diastolic filling wave A velocity and deceleration time of the E wave DTE will be measured at the tips of the mitral leaflets The DTE will be calculated as the time from E to the time when the descent of E intercepts the zero line The duration of the transmitral A wave velocity will also be measured The peak velocity of pulmonary venous PV systolic S and diastolic D flow the peak velocity of PV backward flow at atrial contraction PVa and the PVa wave duration PVa dur will be measured with the sample volume placed in the right upper pulmonary vein in the four-chamber axis view The difference between the transmitral A wave duration Adur and PVa dur will be derived as an indirect index of increased LV filling pressures according to the standard method Tissue Doppler will be used to calculate the Ee ratio
All digital echocardiograms will be analyzed offline on a dedicated workstation by three independent observers blind to clinical data and reviewed by the same experienced reader Measurements will be expressed as an average of three cycles in sinus rhythm and from three to five cycles in atrial fibrillation
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None