Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-02-22 @ 5:30 AM
Study NCT ID:
NCT03921905
Status:
COMPLETED
Last Update Posted:
2024-12-03
First Post:
2019-04-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Peripheral Artery Disease in Patients With Stable Coronary Artery Disease in General Practice: Prevalence, Management and Clinical Outcomes.
Sponsor:
Mario Negri Institute for Pharmacological Research
Organization:
Study Overview
Official Title:
Peripheral Artery Disease in Patients With Stable Coronary Artery Disease in General Practice: Prevalence, Management and Clinical Outcomes.
Status:
COMPLETED
Status Verified Date:
2024-11
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:
PAD&CAD
Brief Summary:
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
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?: