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

NCT03921905 | Completed

• 1 other identifier: IRFMN-7825
• Study Type: observational
• Target: 713
• Locations: 1 country
• Sites: 4

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.

Conditions

Peripheral Artery Disease

Keywords

Peripheral Artery Disease; Coronary Artery Disease; General Practice; Ankle-brachial index (ABI)

Outcome Measures

Primary Outcomes (1)

• To know the prevalence of PAD in patients with CAD using the automatic device MESI ankle-brachial pressure index (ABPI) MD®

  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.

  1 day

Secondary Outcomes (39)

• To measure the Blood pressure (mmHg)

  1 day

• To measure the Heart rate (bpm)

  1 day

• To measure the Weight (kg)

  1 day

• To measure the Height (cm)

  1 day

• To measure the Body mass index (Kg/m2)

  1 day

Other Outcomes (10)

• The incidence of Acute coronary syndrome

  12 months

• The incidence of Stroke

  12 months

• The incidence of Transient ischemic attack

  12 months

Study Arms (1)

Patients with CAD

In this study will be included patients with stable CAD

Diagnostic Test: ABI measurement

Interventions

ABI measurement DIAGNOSTIC_TEST

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

Patients with CAD

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of stable CAD in charge of GPs, giving the consent to participate in the study.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Mario Negri Institute for Pharmacological Research: lead
• Bayer: collaborator

Study Sites (4)

MEDICOOP Genova

Genova, GE, 16165, Italy

Location

Cooperativa Medici Milano Centro

Milan, MI, 20154, Italy

Location

MEDICOOP S. Agata

Reggio Calabria, RC, 89134, Italy

Location

ROMAMED Service

Rome, RM, 00137, Italy

Location

Related Publications (1)

• 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.

  PMID: 39347889 RESULT

MeSH Terms

Conditions

Peripheral Arterial Disease; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases

Study Officials

• Marta Baviera, PharmD

  Istituto Di Ricerche Farmacologiche Mario Negri

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: April 19, 2019
• Study Start: September 25, 2019
• Primary Completion: December 15, 2022
• Study Completion: November 30, 2023
• Last Updated: December 3, 2024

Record last verified: 2024-11

Locations

IT (4)