Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06215248

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Peripheral Artery Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Heart Diseases Heart Failure Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

35 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. left ventricular global longitudinal strain (GLS)

    Time frame: after enrollment and one year later

    assessed by deformation analysis with echocardiography

Secondary outcomes

  1. other echocardiographic parameters

    Time frame: after enrollment and one year later

    left ventricular ejection fraction, left atrial strain, lateral, medial and averaged E/E', left atrial volume, maximal tricuspid regurgitation velocity, right ventricular strain

  2. heart failure diagnosis

    Time frame: after enrollment and if necessary, reassessment one year later

    according to European Society of Cardiology year 2021 heart failure guideline (i.e assessment of symptoms, ECG, natriuretic peptides)

  3. arterial stiffness

    Time frame: after enrollment and one year later

    peripheral/central blood pressure, augmentation index, pulse wave velocity in aorta

  4. cardiac- and renal injury markers

    Time frame: after enrollment and one year later

    high-sensitivoty troponin T, natriuretic peptides (NT-proBNP), cystatine C, creatinine, urea, calculated eGFR

  5. metabolomics

    Time frame: after enrollment and one year later

    low molecular weight metabolites

  6. markers of oxidative stress

    Time frame: after enrollment and one year later

    oxidated LDL, interleukine-18, myeloperoxidase, isoprostanes

Study contacts

Contact information is provided by the study sponsor or research team.

Jaak Kals, PhD

CONTACT

[email protected]

731 8292 ext. +372

Sponsors and collaborators

Lead sponsor

Tartu University Hospital

Other

Registry information

Official study title

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

Acronym: MEDAL

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 22, 2024
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.