Status:
RECRUITING
Myocardial Dysfunction Evaluation in Lower Extremity Arterial Disease Patients With Deformation Analysis
Lead Sponsor:
Tartu University Hospital
Conditions:
Peripheral Artery Disease
Heart Failure
Eligibility:
All Genders
35-85 years
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, metabolomi...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT06215248
Start Date
February 1 2024
End Date
December 31 2026
Last Update
December 16 2025
Active Locations (1)
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1
Tartu University Hospital
Tartu, Estonia