Clinical trial NCT05628948: Vascular Lab Resource (VLR) Biorepository
Official title: Vascular Lab Resource (VLR) Biorepository Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiovascular Diseases
Metabolic Disease
Peripheral Artery Disease
Carotid Disease
Aneurysmal Disease
Venous Disease
Thrombosis
Lymphedema
Lipedema
Non-Atherosclerotic Chronic Arterial Occlusive Disease
Vasculitis
Fibromuscular Dysplasia
Arterial Dissection
May-Thurner Syndrome
Thoracic Outlet Syndrome
Vasospasm
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2022-11-29
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are with or at risk for cardiovascular or metabolic disease.

Brief summary: This is a study of biomarkers obtained from prospectively collected subject samples and their correlation with cardiovascular and metabolic diseases. The purpose of this initiative is to develop an enduring tool to allow for collaborative research between clinicians at Cleveland Clinic Main Campus and basic scientists at the Lerner Research Institute. This collaboration will allow resources to be available to clinical and basic researchers alike. This tool will enable research of vascular disease in the Vascular Lab and will leverage this valuable asset to the fullest extent to allow for interdepartmental collaboration.

Detailed description: We are proposing a study of biomarkers obtained from prospectively collected subject samples and their correlation with cardiovascular and metabolic diseases. The purpose of this initiative is to develop an enduring tool to allow for collaborative research between clinicians at Cleveland Clinic Main Campus and basic scientists at the Lerner Research Institute. This collaboration will allow resources to be available to clinical and basic researchers alike. This tool will enable research of vascular disease in the Vascular Lab and will leverage this valuable asset to the fullest extent to allow for interdepartmental collaboration.

The care of subjects with vascular and metabolic diseases is very fragmentary, and they remain underserved clinically and under-studied. We will capitalize on the highly collaborative clinical environment in HVI and other clinical institutes to develop and constantly utilize a vascular biobank.

This protocol will study blood, urine, and/or stool samples and clinical data from subjects with cardiovascular and/or metabolic diseases including: peripheral artery disease, carotid disease, aneurysmal disease, chronic venous disease, thrombosis, lymphedema and lipedema, non-atherosclerotic arterial stenosis (vasculitis, fibromuscular dysplasia, arterial dissection and aneurysmal disease, May-Thurner Syndrome etc.), compressive and spastic disorders (thoracic outlet syndrome, vasospasm). This initiative will allow for the opportunity to explore pathways of thrombosis, inflammation, gut microbiome, alterations in cell signaling, lipid metabolism and other metabolic pathways in vascular diseases. Further, this study will enhance and expand ongoing efforts in the Vascular Lab to collect data for the purpose of quality control and safety. The specimen sample collection will enable biochemical and genetic testing on participants once sufficient numbers are attained.

Eligibility criteria: Inclusion Criteria:

1. 18 years or older
2. Subjects capable of providing informed consent document
3. Subjects with diagnosed with or at risk for cardiovascular and metabolic diseases

Exclusion Criteria:

1. Known life expectancy of ≤ 6 months at the time of enrollment
2. Known current pregnancy
3. Severe Anemia (last documented hemoglobin \< 7.0 g/dL)

Primary outcomes:
measure: To collect blood, urine, and/or stool samples for biorepository
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Scott Cameron, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: