Lower Extremity Arterial Disease (Fontaine Stages IIb-IV)PREDICTORNCT04143386
Prognostic Hemodynamic and Metabolic Profiles of Late Stage Lower Extremity Arterial Disease
An observational study of Lower Extremity Arterial Disease (Fontaine Stages IIb-IV), run by University of Tartu at 1 site in Estonia.
Trial summary
Late stage lower extremity arterial disease (LEAD) is known to be associated with hemodynamic and metabolic abnormalities and very poor long-term prognosis. The prognostic value of hemodynamic and metabolic profiling, however, is yet to be determined in this patient group. Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Lower Extremity Arterial Disease (Fontaine Stages IIb-IV)
- How many people
- 750 participants
- Where
- 1 siteEstonia
- Study dates
- 4 Nov 2019to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: Patients with symptomatic lower extremity arterial disease referred to Tartu University Hospital for revascularization (angioplasty/stenting or bypass surgery).
Who may be able to join
None listed.
Who cannot join
- Fontaine stage I-IIa;
- acute limb ischemia;
- age <35 or >85 years;
- fasting < 6 hours;
- time since the last use of tobacco products < 4 hours;
- body mass index ≥ 40 kg/m2
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- blood pressure ≥ 180/120mmHg;
- unstable angina;
- atrial fibrillation at the time of presentation;
- myocardial infarction, stroke or TIA during the preceding 3 months;
- any revascularization during the preceding 1 month;
- severe heart failure (NYHA IV);
- clinically significant heart valve disease;
- severe physical disability (other than limb ischemia);
- acute infectious disease;
- active malignancy or chemotherapy or disease-free < 5 years;
- type 1 diabetes;
- uncompensated thyrotoxicosis/hypothyroidism or other clinically significant endocrine disorders;
- moderate to severe asthma (GINA 2016);
- severe chronic obstructive pulmonary disease (mMRC grade 3-4)
- acute (KDIGO 2012) or chronic renal disease (eGFR-EPI <30mL/min/1.73 m2);
- clinically significant acute or chronic liver disease;
- severe anemia (<80 g/L);
- clinically significant neuroinflammatory or neurodegenerative disease;
- active rheumatism;
- clinically significant connective tissue disease;
- alcoholism or drug abuse;
- psychotic disorders
Trial locations and contacts
1 site in 1 country.
Estonia1 site, 1 recruiting
- Recruiting
Tartu University Hospital
Tartu, Tartu, 50406
Jaak Kals, MD, PhD, +372 731 8292, jaak.kals@kliinikum.ee
About this study
Late stage lower extremity arterial disease (LEAD) is known to be associated with hemodynamic and metabolic abnormalities and very poor long-term prognosis. The prognostic value of hemodynamic and metabolic profiling, however, is yet to be determined in this patient group.
Current study aims to identify novel prognostic biomarkers for better risk stratification of late stage LEAD patients. It also allows to determine associations between hemodynamic/arterial stiffness indices, low-molecular weight metabolites and other substances (e.g. mediators of inflammation and bone-mineral metabolism, cardiac and kidney injury biomarkers, microRNAs) thus providing potentially valuable insight into the pathogenic mechanisms of this disease.
- Keywords
- lower extremity arterial disease, hemodynamics, arterial stiffness, metabolism, metabolomics, inflammation, oxidative stress, biomarkers, prognosis
- Medical subject headings
- Inflammation
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of major adverse cardiovascular events, major adverse limb events and deaths
A composite of any of the following events, as documented by patients' hospital or death records:
- nonfatal myocardial infarction or stroke
- fatal myocardial infarction or stroke
- hospitalization for angioplasty or bypass surgery for coronary or peripheral vessel disease
- LEAD-related major lower extremity amputation
- other cardiovascular deaths (cardiac arrest, lethal arrhythmia, heart failure, aortic dissection or rupture)
- non-cardiovascular deaths
Measured: 5 years
Secondary outcomes (5)
Number of fatal cardiovascular events
Measured: 5 years
Number of non-fatal cardiovascular events
Measured: 5 years
Number of LEAD-related major lower extremity amputations
Measured: 5 years
Number of hospitalizations for angioplasty or bypass surgery for coronary or peripheral vessel disease
Measured: 5 years
Number of deaths from all causes
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start4 Nov 2019 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Extremity Arterial Disease (Fontaine Stages IIb-IV)Studies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tartu
- Sponsor type
- University, hospital or other
- Collaborators
- Estonian Science Foundation, Tartu University Hospital
- Responsible party
- Principal investigator, Jaak Kals, University of Tartu
- Investigators
- Jaak Kals, MD, PhD, Principal investigator, University of TartuJaan Eha, MD, PhD, Study chair, University of TartuMihkel Zilmer, dr. med., Study chair, University of TartuKaido Paapstel, MD, PhD, Study director, University of TartuKaspar Tootsi, MD, PhD, Study chair, University of TartuKarl Kuusik, MD, Study chair, University of TartuTuljo Ööbik, MD, Study chair, University of TartuRiina Kaur, Study chair, University of Tartu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04143386
- Sponsor's protocol ID
- 283T10
- Acronym
- PREDICTOR
- Status last verified
- Oct 2019
- First submitted
- 24 Oct 2019
- Last updated
- 29 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Hemodynamic and Metabolic Profiles of Late Stage Lower Extremity Arterial Disease
- ClinicalTrials.gov ID
- NCT04143386
- Acronym / sponsor ID
- PREDICTOR / 283T10
- Keywords
- lower extremity arterial disease, hemodynamics, arterial stiffness, metabolism, metabolomics, inflammation, oxidative stress, biomarkers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- University of TartuUniversity, hospital or other
- Collaborators
- Estonian Science Foundation, Tartu University Hospital
- Study start
- 4 Nov 2019 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 29 Oct 2019 (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.
Late stage lower extremity arterial disease (LEAD) is known to be associated with hemodynamic and metabolic abnormalities and very poor long-term prognosis. The prognostic value of hemodynamic and metabolic profiling, however, is yet to be determined in this patient group.
Current study aims to identify novel prognostic biomarkers for better risk stratification of late stage LEAD patients. It also allows to determine associations between hemodynamic/arterial stiffness indices, low-molecular weight metabolites and other substances (e.g. mediators of inflammation and bone-mineral metabolism, cardiac and kidney injury biomarkers, microRNAs) thus providing potentially valuable insight into the pathogenic mechanisms of this disease.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with symptomatic lower extremity arterial disease referred to Tartu University Hospital for revascularization (angioplasty/stenting or bypass surgery).
Key inclusion criteria (0 listed)
Key exclusion criteria (28 listed)
- Fontaine stage I-IIa;
- acute limb ischemia;
- age <35 or >85 years;
- fasting < 6 hours;
- time since the last use of tobacco products < 4 hours;
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
Number of major adverse cardiovascular events, major adverse limb events and deaths
Time frame: 5 years
A composite of any of the following events, as documented by patients' hospital or death records: 1. nonfatal myocardial infarction or stroke 2. fatal myocardial infarction or stroke 3. hospitalization for angioplasty or bypass surgery for coronary or peripheral vessel disease 4. LEAD-related major lower extremity amputation 5. other cardiovascular deaths (cardiac arrest, lethal arrhythmia, heart failure, aortic dissection or rupture) 6. non-cardiovascular deaths
5 secondary outcomes
Number of fatal cardiovascular events
Time frame: 5 years
Number of non-fatal cardiovascular events
Time frame: 5 years
Number of LEAD-related major lower extremity amputations
Time frame: 5 years
Number of hospitalizations for angioplasty or bypass surgery for coronary or peripheral vessel disease
Time frame: 5 years
Number of deaths from all causes
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2019.
- Endothelial Research CentreLink provided by the sponsor.
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. This study is not recruiting at the moment.
Jaak Kals, MD, PhD principal investigator
University of Tartu
Jaan Eha, MD, PhD study chair
University of Tartu
Mihkel Zilmer, dr. med. study chair
University of Tartu
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 Lower Extremity Arterial Disease (Fontaine Stages IIb-IV), run by University of Tartu 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 0 inclusion and 28 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: status not confirmed, as of the sponsor's last update on 29 Oct 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jaak Kals, MD, PhD (+372 731 8292, jaak.kals@kliinikum.ee), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of major adverse cardiovascular events, major adverse limb events and deaths (time frame: 5 years). 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 29 Oct 2019.