Peripheral Artery DiseaseMEDALNCT06215248
Myocardial Dysfunction Evaluation in Lower Extremity Arterial Disease Patients With Deformation Analysis
An observational study of Peripheral Artery Disease and Heart Failure, run by Tartu University Hospital at 1 site in Estonia.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Peripheral Artery Disease, Heart Failure
- Type of treatment
- Injection or infusion
- How many people
- 162 participants
- Where
- 1 siteEstonia
- Study dates
- 1 Feb 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with cardiovascular risk factors
Who may be able to join
- Fontaine I-IV class symptoms
- Confirmed diagnosis of LEAD
- Age 35-85
- Has to have at least of the following: hypertension, diabetes, coronary artery disease or the patient smokes
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Estonia1 site, 1 recruiting
- Recruiting
Tartu University Hospital
Tartu
Liis Roine, MD, +372 731 8457, liis.roine@kliinikum.ee
About this study
Official title: Assessment of Dysfunction in Left Cardiac Chambers With Strain-analyses in Patients With Lower Extremity Arterial Disease
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.
- Conditions
- Peripheral Artery Disease, Heart Failure
- Medical subject headings
- Peripheral Arterial Disease, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| LEAD | LEAD diagnosis confirmed by by ankle-brachial index (≤0,9 or >1,3) or angiography. Fontaine I-IV class symptoms. | |
| Controls | Matched with LEAD group's patients as much as possible for age, sex, smoking history, hypertension, diabetes, coronary artery disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
left ventricular global longitudinal strain (GLS)
assessed by deformation analysis with echocardiography
Measured: after enrollment and one year later
Secondary outcomes (6)
other echocardiographic parameters
left ventricular ejection fraction, left atrial strain, lateral, medial and averaged E/E', left atrial volume, maximal tricuspid regurgitation velocity, right ventricular strain
Measured: after enrollment and one year later
heart failure diagnosis
according to European Society of Cardiology year 2021 heart failure guideline (i.e assessment of symptoms, ECG, natriuretic peptides)
Measured: after enrollment and if necessary, reassessment one year later
arterial stiffness
peripheral/central blood pressure, augmentation index, pulse wave velocity in aorta
Measured: after enrollment and one year later
cardiac- and renal injury markers
high-sensitivoty troponin T, natriuretic peptides (NT-proBNP), cystatine C, creatinine, urea, calculated eGFR
Measured: after enrollment and one year later
metabolomics
low molecular weight metabolites
Measured: after enrollment and one year later
markers of oxidative stress
oxidated LDL, interleukine-18, myeloperoxidase, isoprostanes
Measured: after enrollment and one year later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start1 Feb 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tartu University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaak Kals, Tartu University Hospital
- Investigators
- Jaak Kals, PhD, Principal investigator, Tartu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06215248
- Sponsor's protocol ID
- 23105
- Acronym
- MEDAL
- Status last verified
- Dec 2025
- First submitted
- 10 Jan 2024
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Dysfunction in Left Cardiac Chambers With Strain-analyses in Patients With Lower Extremity Arterial Disease
- ClinicalTrials.gov ID
- NCT06215248
- Acronym / sponsor ID
- MEDAL / 23105
- Conditions
- Peripheral Artery Disease, Heart Failure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Tartu University HospitalUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LEAD | – | –LEAD diagnosis confirmed by by ankle-brachial index (≤0,9 or >1,3) or angiography. Fontaine I-IV class symptoms. |
| Controls | – | –Matched with LEAD group's patients as much as possible for age, sex, smoking history, hypertension, diabetes, coronary artery disease. |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cardiovascular risk factors
Key inclusion criteria (4 listed)
- Fontaine I-IV class symptoms
- Confirmed diagnosis of LEAD
- Age 35-85
- Has to have at least of the following: hypertension, diabetes, coronary artery disease or the patient smokes
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
left ventricular global longitudinal strain (GLS)
Time frame: after enrollment and one year later
assessed by deformation analysis with echocardiography
6 secondary outcomes
other echocardiographic parameters
Time frame: after enrollment and one year later
heart failure diagnosis
Time frame: after enrollment and if necessary, reassessment one year later
arterial stiffness
Time frame: after enrollment and one year later
cardiac- and renal injury markers
Time frame: after enrollment and one year later
metabolomics
Time frame: after enrollment and one year later
markers of oxidative stress
Time frame: after enrollment and one year later
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Endothelial Research CentreLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Peripheral Arterial Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jaak Kals, PhD principal investigator
Tartu University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Artery Disease and Heart Failure, run by Tartu University Hospital at 1 site in Estonia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Estonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jaak Kals, PhD (731 8292 ext. +372, jaak.kals@ut.ee), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
left ventricular global longitudinal strain (GLS) (time frame: after enrollment and one year later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.