Lower Extremity Arterial Disease (Fontaine Stages IIb-IV) Clinical Trial
— PREDICTOROfficial title:
Prognostic Hemodynamic and Metabolic Profiles of Late Stage Lower Extremity Arterial Disease
| NCT number | NCT04143386 |
| Other study ID # | 283T10 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | November 4, 2019 |
| Est. completion date | December 31, 2025 |
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.
| Status | Recruiting |
| Enrollment | 750 |
| Est. completion date | December 31, 2025 |
| Est. primary completion date | December 31, 2024 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 35 Years to 85 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Estonia | Tartu University Hospital | Tartu | Tartumaa |
| Lead Sponsor | Collaborator |
|---|---|
| University of Tartu | Estonian Science Foundation, Tartu University Hospital |
Estonia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of major adverse cardiovascular events, major adverse limb events and deaths | A composite of any of the following events, as documented by patients' hospital or death records: nonfatal myocardial infarction or stroke fatal myocardial infarction or stroke hospitalization for angioplasty or bypass surgery for coronary or peripheral vessel disease LEAD-related major lower extremity amputation other cardiovascular deaths (cardiac arrest, lethal arrhythmia, heart failure, aortic dissection or rupture) non-cardiovascular deaths |
5 years | |
| Secondary | Number of fatal cardiovascular events | 5 years | ||
| Secondary | Number of non-fatal cardiovascular events | 5 years | ||
| Secondary | Number of LEAD-related major lower extremity amputations | 5 years | ||
| Secondary | Number of hospitalizations for angioplasty or bypass surgery for coronary or peripheral vessel disease | 5 years | ||
| Secondary | Number of deaths from all causes | 5 years |