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

Recruiting

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

• Registration Number: NCT04143386
• Lead Sponsor: University of Tartu

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-10
• Study First Submitted: 2019-10-24
• Study First Submitted QC: 2019-10-28
• Last Update Submitted: 2019-10-28
• Study First Posted: 2019-10-29
• Last Update Posted: 2019-10-29
• Study Start: 2019-11-04
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 750

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of major adverse cardiovascular events, major adverse limb events and deaths	5 years	A composite of any of the following events, as documented by patients' hospital or death records: 1. nonfatal myocardial infarction or stroke; 2. fatal myocardial infarction or stroke; 3. hospitalization for angioplasty or bypass surgery for coronary or peripheral vessel disease; 4. LEAD-related major lower extremity amputation; 5. other cardiovascular deaths (cardiac arrest, lethal arrhythmia, heart failure, aortic dissection or rupture); 6. non-cardiovascular deaths

Secondary Outcome Measures

Name	Time	Method
Number of fatal cardiovascular events	5 years
Number of LEAD-related major lower extremity amputations	5 years
Number of non-fatal cardiovascular events	5 years
Number of hospitalizations for angioplasty or bypass surgery for coronary or peripheral vessel disease	5 years
Number of deaths from all causes	5 years

Trial Locations

Locations (1)

Tartu University Hospital; 🇪🇪 Tartu, Tartumaa, Estonia