ABI measurement
Diagnostic TestABI measurement wil be done with an automatic device to diagnose PAD in patients with CAD
NCT Number: NCT03921905
Patients with lower extremity peripheral artery disease (PAD) are at risk of developing major adverse limb events and have a similar cardiovascular (CV) morbidity and mortality to those with coronary artery disease (CAD) with which is associated in most cases with a more severe prognosis. Because of higher risk conferred by concomitant PAD an early diagnosis is recommended in subjects with CAD. PAD can be diagnosed relatively easily and noninvasively with the ankle-brachial index (ABI) measure. An ABI ≤0.9 is an indicator of the presence of lower extremity PAD, indicating athero-occlusive arterial disease while >1.3/1.4 indicates an incompressible ankle arteries. However, ABI is not routinely applied in the clinical practice. Data on prevalence of PAD are scanty and in patients with stable CAD are lacking. The under-diagnosis of PAD may be a barrier to the use of treatments to improve prognosis. The primary aim of this study is to assess the coexistence of PAD in subjects with stable CAD and to evaluate the management and the prognosis of these patients in primary care at 12-month after the inclusion in the study.
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Observational
MEDICOOP Genova, Genova, GE, Italy
National, multicentre, observational, prospective study. This study will be carried out with the collaboration with Study Center for Primary Care and with the Italian Society of Angiology and Vascular Medicine (SIAPAV).
The eligible patients with stable CAD will be called by General Practitioners (GPs).
For all patients who agree to participate in the study and sign the consent, two visits will be done at baseline and after 12 months.
At baseline will be collected information on socio-demographic and anthropometric data, blood pressure, heart rate, CV risk factors, medical history, lifestyle habits, PAD stage (for patient with abnormal ABI) and pharmacological therapy. ABI measurement will be done using an automatic simple device. In case of abnormal ABI value, a SIAPAV vascular specialist, at GP's office, will confirm it using the standard manual continuous wave (CW) Doppler.
At follow-up visit the following information will be collected the: referral to vascular specialist (if requested, at discretion of the GP), relevant change in pharmacological therapy, major CV events and progression of PAD, limb and coronary artery revascularizations, amputations, major bleeding, and death.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
ABI measurement wil be done with an automatic device to diagnose PAD in patients with CAD
Time frame: 1 day
The prevalence of PAD will be diagnosed measuring the ankle-brachial-index (ABI) determined by dividing the higher systolic pressure measured at the ankle of both legs by the brachial arterial systolic pressure. An ABI value <=0.9 is an indicator of the presence of PAD indicating athero-occlusive arterial disease while >1.3/1.4 indicates an incompressible ankle arteries. The ABI measurement will be performed using the automatic device MESI ABPI MD.
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The Mediterranean Diet Questionnaire (Prevention with a Mediterranean Diet PREDIMED -14 Items) will be administered
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The Physical activity Questionnaire (BRFSS 2 items) will be administered
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Time frame: 12 months
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Time frame: 12 months
Mario Negri Institute for Pharmacological Research
Other
Acronym: PAD&CAD
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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