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

NCT04143386 | Unknown

• 1 other identifier: 283T10
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Extremity Arterial Disease (Fontaine Stages IIb-IV)

Keywords

lower extremity arterial disease; hemodynamics; arterial stiffness; metabolism; metabolomics; inflammation; oxidative stress; biomarkers; prognosis

Outcome Measures

Primary Outcomes (1)

• 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: 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

  5 years

Secondary Outcomes (5)

• 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

• Age: 35 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with symptomatic lower extremity arterial disease referred to Tartu University Hospital for revascularization (angioplasty/stenting or bypass surgery).

You may not qualify if:

• 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;

Sponsors & Collaborators

• University of Tartu: lead
• Estonian Science Foundation: collaborator
• Tartu University Hospital: collaborator

Study Sites (1)

Tartu University Hospital

Tartu, Tartu, 50406, Estonia

RECRUITING

Related Links

• Endothelial Research Centre

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, plasma, urine

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jaak Kals, MD, PhD

  University of Tartu

  PRINCIPAL INVESTIGATOR

• Jaan Eha, MD, PhD

  University of Tartu

  STUDY CHAIR

• Mihkel Zilmer, dr. med.

  University of Tartu

  STUDY CHAIR

• Kaido Paapstel, MD, PhD

  University of Tartu

  STUDY DIRECTOR

• Kaspar Tootsi, MD, PhD

  University of Tartu

  STUDY CHAIR

• Karl Kuusik, MD

  University of Tartu

  STUDY CHAIR

• Tuljo Ööbik, MD

  University of Tartu

  STUDY CHAIR

• Riina Kaur

  University of Tartu

  STUDY CHAIR

Central Study Contacts

Jaak Kals, MD, PhD

CONTACT

+372 731 8292; jaak.kals@kliinikum.ee

Kaido Paapstel, MD, PhD

CONTACT

+372 731 8317; kaido.paapstel@kliinikum.ee

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 24, 2019
• First Posted: October 29, 2019
• Study Start: November 4, 2019
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: October 29, 2019

Record last verified: 2019-10

Locations

ES (1)