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

NCT ID: NCT04143386

Last Updated: 2019-10-29

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 750 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-11-04
• Study Completion Date: 2025-12-31

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)

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Estonian Science Foundation

OTHER_GOV

Sponsor Role: collaborator

Tartu University Hospital

OTHER

Sponsor Role: collaborator

University of Tartu

OTHER

Sponsor Role: lead

Responsible Party

Jaak Kals

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jaak Kals, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Tartu

Jaan Eha, MD, PhD

Role: STUDY_CHAIR

University of Tartu

Mihkel Zilmer, dr. med.

Role: STUDY_CHAIR

University of Tartu

Kaido Paapstel, MD, PhD

Role: STUDY_DIRECTOR

University of Tartu

Kaspar Tootsi, MD, PhD

Role: STUDY_CHAIR

University of Tartu

Karl Kuusik, MD

Role: STUDY_CHAIR

University of Tartu

Tuljo Ööbik, MD

Role: STUDY_CHAIR

University of Tartu

Riina Kaur

Role: STUDY_CHAIR

University of Tartu

Locations

Tartu University Hospital

Tartu, Tartu, Estonia

Site Status: RECRUITING

Countries

Estonia

Central Contacts

Jaak Kals, MD, PhD

Role: CONTACT

jaak.kals@kliinikum.ee

+372 731 8292

Kaido Paapstel, MD, PhD

Role: CONTACT

kaido.paapstel@kliinikum.ee

+372 731 8317

Facility Contacts

Jaak Kals, MD, PhD

Role: primary

jaak.kals@kliinikum.ee

+372 731 8292

Related Links

https://endothelialcentre.ut.ee/

Endothelial Research Centre

Other Identifiers

283T10

Identifier Type: -

Identifier Source: org_study_id