Prognostic Hemodynamic and Metabolic Profiles of Late Stage Lower Extremity Arterial Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lower Extremity Arterial Disease (Fontaine Stages IIb-IV)
- Sponsor
- University of Tartu
- Enrollment
- 750
- Locations
- 1
- Primary Endpoint
- Number of major adverse cardiovascular events, major adverse limb events and deaths
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
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.
Investigators
Jaak Kals
Principal Investigator
University of Tartu
Eligibility Criteria
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;
Outcomes
Primary Outcomes
Number of major adverse cardiovascular events, major adverse limb events and deaths
Time Frame: 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 Outcomes
- Number of fatal cardiovascular events(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 LEAD-related major lower extremity amputations(5 years)
- Number of deaths from all causes(5 years)