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

Tartu University Hospital

Status

Enrolling

Conditions

Peripheral Artery Disease

Heart Failure

Study type

Observational

Funder types

Other

Identifiers

NCT06215248

23105

Details and patient eligibility

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.

Enrollment

162 estimated patients

Sex

All

Ages

35 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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