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

Sponsor

University of Tartu (Other)

Overall Status

Recruiting

CT.gov ID

NCT04143386

Collaborator

Estonian Science Foundation (Other), Tartu University Hospital (Other)

750

Enrollment

Location

73.9

Anticipated Duration (Months)

10.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lower Extremity Arterial Disease (Fontaine Stages IIb-IV)

Study Design

Study Type:

Observational

Anticipated Enrollment :

750 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Nov 4, 2019

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2025

Outcome Measures

Primary Outcome Measures

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: 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

Secondary Outcome Measures

Number of fatal cardiovascular events [5 years]
Number of non-fatal cardiovascular events [5 years]
Number of LEAD-related major lower extremity amputations [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 85 Years

Sexes Eligible for Study:

All

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