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Peripheral Artery Disease in Patients With Stable Coronary Artery Disease in General Practice: Prevalence, Management and Clinical Outcomes.

NCT ID: NCT03921905

Last Updated: 2024-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

713 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-09-25

Study Completion Date

2023-11-30

Brief Summary

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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

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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.

Conditions

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Peripheral Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with CAD

In this study will be included patients with stable CAD

ABI measurement

Intervention Type DIAGNOSTIC_TEST

ABI measurement wil be done with an automatic device to diagnose PAD in patients with CAD

Interventions

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ABI measurement

ABI measurement wil be done with an automatic device to diagnose PAD in patients with CAD

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patients of both sexes with a diagnosis of stable CAD as follows: acute myocardial infarction or percutaneous coronary revascularization or coronary artery bypass graft surgery occured at least 12 months before entering the study or chronic stable angina.

Exclusion Criteria

* Mental illness limiting the capacity of self-care or any condition limiting seriously the life expectancy less than 12 months.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role collaborator

Mario Negri Institute for Pharmacological Research

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marta Baviera, PharmD

Role: STUDY_DIRECTOR

Istituto Di Ricerche Farmacologiche Mario Negri

Locations

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MEDICOOP Genova

Genova, GE, Italy

Site Status

Cooperativa Medici Milano Centro

Milan, MI, Italy

Site Status

MEDICOOP S. Agata

Reggio Calabria, RC, Italy

Site Status

ROMAMED Service

Rome, RM, Italy

Site Status

Countries

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Italy

References

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Baviera M, Foresta A, Fernandez LO, Torrigiani G, Tettamanti M, Roncaglioni MC, Cimminiello C; PAD, C. A. D. Study Group. Peripheral artery disease in patients with stable coronary artery disease in general practice: results from an Italian nationwide study-PAD & CAD study. Intern Emerg Med. 2025 Jan;20(1):159-169. doi: 10.1007/s11739-024-03771-9. Epub 2024 Sep 30.

Reference Type RESULT
PMID: 39347889 (View on PubMed)

Other Identifiers

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IRFMN-7825

Identifier Type: -

Identifier Source: org_study_id