Heart muscle strain imaging in people with lower limb artery disease
Assessment of Dysfunction in Left Cardiac Chambers With Strain-analyses in Patients With Lower Extremity Arterial Disease
This study tests whether people with lower extremity arterial disease have subtle heart muscle problems detected by strain imaging that relate to changes in blood metabolites.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 162 (estimated) |
| Ages | 35 Years to 85 Years |
| Sex | All |
| Sponsor | Tartu University Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Tartu) |
| Trial ID | NCT06215248 on ClinicalTrials.gov |
What this trial studies
This single-center observational study at Tartu University Hospital uses deformation (strain) echocardiography and blood metabolomic profiling to characterize cardiac dysfunction in patients with lower extremity arterial disease (LEAD). Investigators will enroll a LEAD group (Fontaine I–IV) and a control group aged 35–85 with cardiovascular risk factors, performing standardized echocardiographic strain analyses, blood sampling, and clinical assessment of target organ damage. No treatments are given; researchers will compare strain metrics and metabolite patterns between groups and correlate those measures with signs of organ damage. The approach aims to identify subclinical myocardial dysfunction and metabolic signatures associated with LEAD.
Who should consider this trial
Good fit: Ideal candidates are adults 35–85 with confirmed lower extremity arterial disease (any Fontaine class), or control participants aged 35–85 who have hypertension, diabetes, coronary artery disease, or a history of smoking.
Not a fit: People outside the 35–85 age range or with known heart failure, significant structural heart disease, recent acute coronary syndrome or stroke, severe pulmonary disease, very high BMI (≥40), chronic severe kidney dysfunction, or implanted cardiac devices are excluded and unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, the work could allow earlier detection and better risk stratification of heart damage in people with leg artery disease, supporting closer monitoring or earlier interventions.
How similar studies have performed: Echocardiographic strain imaging has previously detected subclinical cardiac dysfunction in vascular disease, but combining strain measures with metabolomic profiling specifically in LEAD is relatively novel.
Eligibility criteria
Show full inclusion / 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
Where this trial is running
Tartu
- Tartu University Hospital — Tartu, Estonia (Recruiting)
Study contacts
- Principal investigator: Jaak Kals, PhD — Tartu University Hospital
- Study coordinator: Jaak Kals, PhD
- Email: jaak.kals@ut.ee
- Phone: 731 8292
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.