Novel Risk Factors and Localization of Peripheral Arterial Disease

NCT07233356 | Completed

• 1 other identifier: PAP_RI2_2017/10
• Study Type: observational
• Target: 123
• Locations: 1 country
• Sites: 1

Brief Summary

Background: .Atherosclerotic peripheral arterial disease (PAD) is associated with a high risk of mortality, coronary events and stroke. The distal localization is frequently associated with amputation. Patients from African origin have a higher prevalence of PAD independently of age and other risk factors. In Guadeloupe, French West Indies, infra popliteal localization is more frequent than in France continental associated with different risk factors (88% of hypertension, 2/3 of diabetes). Purpose: Traditional risk factors of PAD are smoking diabetes, hypertension, high lipid levels, age, and family history of cardiovascular events. The role of novel risk factors in PAD has recently been shown: fibrinogen, CRP-us, homocysteine, interleukin 6, the neutrophil-to-lymphocyte ratio, the urinary albumin-to-creatinine ratio, alkaline phosphatases, insulin resistance, uric acid, D dimer, vitamin D deficiency, HBA1C. Thus the purpose of the research is to study the role of novel risk factors in the occurrence of infrapopliteal PAD. The primary criterion is the HBA1C.

Conditions

Atherosclerotic Peripheral Arterial Disease; Hemoglobin A1c Protein, Human; Guadeloupe

Keywords

Hemoglobin A1c; Atherosclerotic peripheral arterial disease; distal localization,; novel risk factors,

Outcome Measures

Primary Outcomes (1)

• Hemoglobin A1c

  pourcentage

  between day 0 to month 3

Secondary Outcomes (10)

• novel risk factors fibrinogen

  between day 0 and month 3

• novel risk factors homocysteine

  between day 0 an month 3

• novel risk factors interleukin 6,

  between day 0 and month 3

• novel risk factors neutrophil-to-lymphocyte ratio,

  between day 0 and month 3

• novel risk factors urinary albumin-to-creatinine ratio

  between day 0 and month 3

Study Arms (2)

group 1

culprit lesion is infra popliteal

group 2

culprit lesion is supra or popliteal

Eligibility Criteria

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

Study Population

Patients having a Doppler ultra sound for known PAD or newly diagnosed PAD at hospital or at vascular doctor's offices will be proposed to participate in the study. PAD will be diagnosed if systolic pressure index\< 0.9 or toe systolic pressure \< 85 mmHg or tissue oxygen saturation \<65 mmHg or if there is a stenosis \> 50 % or an occlusion.. If the culprit lesion is infra popliteal they will be included in group 1. If the culprit lesion is supra or popliteal they will be included in group 2.

You may qualify if:

• men or women aged more than 18 years old
• with PAD diagnosed with systolic pressure index (SPI) \<0.9 or toe systolic pressure \<85 mmHg or tissue oxygen saturation \< 65 mmHg or with stenosis \>50 % or occlusion of one or more arteries
• Patients with or without diabetes
• with stenosis \>50 % or occlusion of one or more arteries, infra popliteal, supra or popliteal
• wishing to take part in the study
• having signed the informed consent
• Patients affiliated or beneficiary of a social security scheme

You may not qualify if:

• Patients aged less than 18 years old
• Patients who do not wish to participate in the study
• Patients with PAD with localization infra popliteal and supra popliteal or popliteal (stenosis \> 50 % or occlusion of an artery at supra popliteal or popliteal level AND infra popliteal level)
• Patients with an history of revascularization at supra popliteal, popliteal or infra popliteal level AND stenosis on a different territory.
• Patients with medial calcific sclerosis without PAD
• PAD from non-atherosclerotic origin
• Patient non-affiliated to the social security scheme
• Pregnant or breastfeeding women

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Guadeloupe: lead

Study Sites (1)

Centre Hospitalier Universitaire de la Guadeloupe

Pointe-à-Pitre, Guadeloupe, 97159, Guadeloupe

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood and urinary samples

Study Officials

• Anne BLANCHET, Doctor

  CHU de la Guadeloupe

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: April 4, 2019
• Primary Completion: April 22, 2025
• Study Completion: April 22, 2025
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

GU (1)