Prognostic Hemodynamic and Metabolic Profiles of Late Stage Lower Extremity Arterial Disease (PREDICTOR)

University of Tartu

Status: Enrolling

Conditions: Lower Extremity Arterial Disease (Fontaine Stages IIb-IV)

Study type: Observational

Funder types: Other

Identifiers

NCT04143386

283T10

Details and patient eligibility

About

Late stage lower extremity arterial disease (LEAD) is known to be associated with hemodynamic and metabolic abnormalities and very poor long-term prognosis. The prognostic value of hemodynamic and metabolic profiling, however, is yet to be determined in this patient group.

Current study aims to identify novel prognostic biomarkers for better risk stratification of late stage LEAD patients. It also allows to determine associations between hemodynamic/arterial stiffness indices, low-molecular weight metabolites and other substances (e.g. mediators of inflammation and bone-mineral metabolism, cardiac and kidney injury biomarkers, microRNAs) thus providing potentially valuable insight into the pathogenic mechanisms of this disease.

Enrollment: 750 estimated patients

Sex: All

Ages: 35 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Exclusion Criteria:

• Fontaine stage I-IIa;
• acute limb ischemia;
• age <35 or >85 years;
• fasting < 6 hours;
• time since the last use of tobacco products < 4 hours;
• body mass index ≥ 40 kg/m2
• blood pressure ≥ 180/120mmHg;
• unstable angina;
• atrial fibrillation at the time of presentation;
• myocardial infarction, stroke or TIA during the preceding 3 months;
• any revascularization during the preceding 1 month;
• severe heart failure (NYHA IV);
• clinically significant heart valve disease;
• severe physical disability (other than limb ischemia);
• acute infectious disease;
• active malignancy or chemotherapy or disease-free < 5 years;
• type 1 diabetes;
• uncompensated thyrotoxicosis/hypothyroidism or other clinically significant endocrine disorders;
• moderate to severe asthma (GINA 2016);
• severe chronic obstructive pulmonary disease (mMRC grade 3-4)
• acute (KDIGO 2012) or chronic renal disease (eGFR-EPI <30mL/min/1.73 m2);
• clinically significant acute or chronic liver disease;
• severe anemia (<80 g/L);
• clinically significant neuroinflammatory or neurodegenerative disease;
• active rheumatism;
• clinically significant connective tissue disease;
• alcoholism or drug abuse;
• psychotic disorders