Identifying biomarkers for late stage lower extremity arterial disease

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

This study is trying to find new markers in the blood that can help doctors better understand and predict the long-term outcomes for patients with late-stage lower extremity arterial disease.

Quick facts

• Study type: Observational
• Enrollment: 750 (estimated)
• Ages: 35 Years to 85 Years
• Sex: All
• Sponsor: University of Tartu (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Tartu, Tartumaa)
• Trial ID: NCT04143386 on ClinicalTrials.gov

What this trial studies

This observational study focuses on patients with late stage lower extremity arterial disease (LEAD) to identify novel prognostic biomarkers that can improve risk stratification. It aims to explore the associations between hemodynamic and arterial stiffness indices, low-molecular weight metabolites, and other relevant substances, providing insights into the disease's pathogenic mechanisms. By profiling hemodynamic and metabolic abnormalities, the study seeks to enhance understanding of the long-term prognosis for these patients.

Who should consider this trial

Good fit: Ideal candidates for this study are patients diagnosed with Fontaine stages IIb-IV of lower extremity arterial disease.

Not a fit: Patients with Fontaine stage I-IIa or those with acute limb ischemia will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved risk assessment and management strategies for patients with late stage lower extremity arterial disease.

How similar studies have performed: While the specific approach of this study may be novel, similar studies have shown promise in identifying prognostic biomarkers in other vascular diseases.

Eligibility 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

Where this trial is running

Tartu, Tartumaa

• Tartu University Hospital — Tartu, Tartumaa, Estonia (Recruiting)

Study contacts

• Principal investigator: Jaak Kals, MD, PhD — University of Tartu
• Study coordinator: Jaak Kals, MD, PhD

Conditions Lower Extremity Arterial Disease; lower extremity arterial disease; hemodynamics; arterial stiffness; metabolism; metabolomics; inflammation; oxidative stress