Myocardial Dysfunction Evaluation in Lower Extremity Arterial Disease Patients With Deformation Analysis

NCT06215248 | Recruiting

• 1 other identifier: 23105
• Study Type: observational
• Target: 162
• Locations: 1 country
• Sites: 1

Brief Summary

Single centre observational study to assess lower extremity arterial disease (LEAD) patients' cardiac dysfunction with strain analyses and to assess connections between cardiac dysfunction, metabolomic changes and target organ damage in LEAD.

Conditions

Peripheral Artery Disease; Heart Failure

Outcome Measures

Primary Outcomes (1)

• left ventricular global longitudinal strain (GLS)

  assessed by deformation analysis with echocardiography

  after enrollment and one year later

Secondary Outcomes (6)

• other echocardiographic parameters

  after enrollment and one year later

• heart failure diagnosis

  after enrollment and if necessary, reassessment one year later

• arterial stiffness

  after enrollment and one year later

• cardiac- and renal injury markers

  after enrollment and one year later

• metabolomics

  after enrollment and one year later

Study Arms (2)

LEAD

LEAD diagnosis confirmed by by ankle-brachial index (≤0,9 or \>1,3) or angiography. Fontaine I-IV class symptoms.

Controls

Matched with LEAD group's patients as much as possible for age, sex, smoking history, hypertension, diabetes, coronary artery disease.

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with cardiovascular risk factors

You may qualify if:

• Fontaine I-IV class symptoms
• Confirmed diagnosis of LEAD
• Age 35-85
• Has to have at least of the following: hypertension, diabetes, coronary artery disease or the patient smokes

You may not qualify if:

• Age \<35 or \>85 years
• BMI ≥40 kg/m²
• Known heart failure in history
• Any acute or chronic autoimmune or rheumatic disease
• Cardiac structural disease in history: inflammatory, infiltrative diseases, nonischemic cardiomyopathies
• Acute coronary syndrome in last 3 months
• Moderate to severe cardiac valvular disease
• Cardiac valvular disease operative/invasive treatment in history
• Cardiac implantable electronic device (CIED)
• Transitory ischemic attack or stroke in last 3 months
• Severe COPD (GOLD C or D)
• Moderate to severe asthma (according to GINA 2022 criteria)
• Untreated hypertension (noninvasive blood pressure measurement ≥180/110 mmHg during recruitment)
• Chronic severe kidney dysfunction (eGFR \<30 ml/min/1,73 m²)
• Malignant tumor with radiation treatment to thorax, oncologic or biologic treatment in history

Sponsors & Collaborators

• Tartu University Hospital: lead

Study Sites (1)

Tartu University Hospital

Tartu, Estonia

RECRUITING

Related Links

• Endothelial Research Centre

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, serum, plasma.

MeSH Terms

Conditions

Peripheral Arterial Disease; Heart Failure

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Heart Diseases

Study Officials

• Jaak Kals, PhD

  Tartu University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jaak Kals, PhD

CONTACT

731 8292; jaak.kals@ut.ee

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Vasology

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: January 22, 2024
• Study Start: February 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)