Myocardial Dysfunction Evaluation in Lower Extremity Arterial Disease Patients With Deformation Analysis
Recruiting · NCT06215248 · Observational (researchers observe without assigning treatment) · Lead sponsor: Tartu University Hospital
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
35 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
1 location listed.
- Tartu University Hospital - Tartu, Estonia