Clinical trial NCT06215248: Myocardial Dysfunction Evaluation in Lower Extremity Arterial Disease Patients With Deformation Analysis
Official title: Assessment of Dysfunction in Left Cardiac Chambers With Strain-analyses in Patients With Lower Extremity Arterial Disease
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Peripheral Artery Disease
Heart Failure
Lead sponsor: Tartu University Hospital
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 162
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cardiovascular risk factors

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, metabolomic changes and target organ damage in LEAD.


Eligibility 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

Primary outcomes:
measure: left ventricular global longitudinal strain (GLS)
timeFrame: after enrollment and one year later
Secondary outcomes:
measure: other echocardiographic parameters
timeFrame: after enrollment and one year later
measure: heart failure diagnosis
timeFrame: after enrollment and if necessary, reassessment one year later
measure: arterial stiffness
timeFrame: after enrollment and one year later
measure: cardiac- and renal injury markers
timeFrame: after enrollment and one year later
measure: metabolomics
timeFrame: after enrollment and one year later
measure: markers of oxidative stress
timeFrame: after enrollment and one year later
Other outcomes:
Locations:
city: Tartu
country: Estonia
facility: Tartu University Hospital
Study officials:
affiliation: Tartu University Hospital
name: Jaak Kals, PhD
role: PRINCIPAL_INVESTIGATOR
References: