NCT04143386|Unknown
Prognostic Hemodynamic and Metabolic Profiles of Late Stage Lower Extremity Arterial Disease
PREDICTOR
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PREDICTOR
Sponsor study identifier
observational
750
1 country
1
Study Start
November 4, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 24, 2019
Actual (reported)October 29, 2019
Actual (reported)November 4, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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: 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 years
Number of fatal cardiovascular events
5 years
Number of non-fatal cardiovascular events
5 years
Number of LEAD-related major lower extremity amputations
5 years
Number of hospitalizations for angioplasty or bypass surgery for coronary or peripheral vessel disease
5 years
Number of deaths from all causes
5 years
Patients with symptomatic lower extremity arterial disease referred to Tartu University Hospital for revascularization (angioplasty/stenting or bypass surgery).
Tartu University Hospital
Tartu, Tartu, 50406, Estonia
Serum, plasma, urine
Jaak Kals, MD, PhD
University of Tartu
Jaan Eha, MD, PhD
University of Tartu
Mihkel Zilmer, dr. med.
University of Tartu
Kaido Paapstel, MD, PhD
University of Tartu
First Submitted
October 24, 2019
First Posted
October 29, 2019
Study Start
November 4, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 31, 2024
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Kaspar Tootsi, MD, PhD
University of Tartu
Karl Kuusik, MD
University of Tartu
Tuljo Ööbik, MD
University of Tartu
Riina Kaur
University of Tartu
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 29, 2019
Record last verified: 2019-10
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Source: ClinicalTrials.gov.
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