Myocardial Dysfunction Evaluation in Lower Extremity Arterial Disease Patients With Deformation Analysis
NCT ID: NCT06215248
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
162 participants
OBSERVATIONAL
2024-02-01
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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LEAD
LEAD diagnosis confirmed by by ankle-brachial index (≤0,9 or \>1,3) or angiography. Fontaine I-IV class symptoms.
No interventions assigned to this group
Controls
Matched with LEAD group's patients as much as possible for age, sex, smoking history, hypertension, diabetes, coronary artery disease.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Confirmed diagnosis of LEAD
* Age 35-85
* Has to have at least of the following: hypertension, diabetes, coronary artery disease or the patient smokes
Exclusion Criteria
* 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
35 Years
85 Years
ALL
No
Sponsors
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Tartu University Hospital
OTHER
Responsible Party
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Jaak Kals
Professor of Vasology
Principal Investigators
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Jaak Kals, PhD
Role: PRINCIPAL_INVESTIGATOR
Tartu University Hospital
Locations
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Tartu University Hospital
Tartu, , Estonia
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Endothelial Research Centre
Other Identifiers
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23105
Identifier Type: -
Identifier Source: org_study_id