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

Assessment of Dysfunction in Left Cardiac Chambers With Strain-analyses in Patients With Lower Extremity Arterial Disease

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Peripheral Artery Disease

• Study Type: Observational
• Enrollment (Estimated): 162

Contacts and Locations

• Study Contact: Name: Jaak Kals, PhD; Phone Number: +372 731 8292; Email: jaak.kals@ut.ee

Study Locations

• Estonia
  • Tartu, Estonia
    • Recruiting
    • Tartu University Hospital
    • Contact: Liis Roine, MD; Phone Number: +372 731 8457; Email: liis.roine@kliinikum.ee

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with cardiovascular risk factors

Description

Inclusion Criteria in LEAD group:

• Fontaine I-IV class symptoms
• Confirmed diagnosis of LEAD

Inclusion Criteria in control group:

• Age 35-85
• Has to have at least of the following: hypertension, diabetes, coronary artery disease or the patient smokes

Exclusion Criteria:

• 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
• Chronic hematologic disease (except for anemia)
• Severe liver dysfunction
• Malignant tumor with <5 years of remission
• Acute or chronic infectious disease
• Anemia with hemoglobin <80 g/L

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
left ventricular global longitudinal strain (GLS)	assessed by deformation analysis with echocardiography	after enrollment and one year later

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
other echocardiographic parameters	left ventricular ejection fraction, left atrial strain, lateral, medial and averaged E/E', left atrial volume, maximal tricuspid regurgitation velocity, right ventricular strain	after enrollment and one year later
heart failure diagnosis	according to European Society of Cardiology year 2021 heart failure guideline (i.e assessment of symptoms, ECG, natriuretic peptides)	after enrollment and if necessary, reassessment one year later
arterial stiffness	peripheral/central blood pressure, augmentation index, pulse wave velocity in aorta	after enrollment and one year later
cardiac- and renal injury markers	high-sensitivoty troponin T, natriuretic peptides (NT-proBNP), cystatine C, creatinine, urea, calculated eGFR	after enrollment and one year later
metabolomics	low molecular weight metabolites	after enrollment and one year later
markers of oxidative stress	oxidated LDL, interleukine-18, myeloperoxidase, isoprostanes	after enrollment and one year later

Collaborators and Investigators

• Sponsor: Tartu University Hospital
• Investigators: Principal Investigator: Jaak Kals, PhD, Tartu University Hospital

Publications and helpful links

Helpful Links

• Endothelial Research Centre

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 10, 2024
• First Submitted That Met QC Criteria: January 10, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Actual): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Heart Failure; Peripheral Arterial Disease
• Other Study ID Numbers: 23105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No