Vascular Lab Resource (VLR) Biorepository

Cardiovascular Diseases Clinical Trial

Official title:

Vascular Lab Resource (VLR) Biorepository Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05628948
• Other study ID #: 19-1451
• Status: Recruiting
• Start date: November 14, 2019
• Est. completion date: June 30, 2031

Study information

• Verified date: November 2023
• Source: The Cleveland Clinic
• Contact: Scott Cameron, MD, PhD
• Phone: 216-444-1680
• Email: cameros3[@]ccf.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 30, 2031
• Est. primary completion date: December 31, 2030
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Aneurysmal Disease
• Arterial Occlusive Diseases
• Cardiovascular Diseases
• Carotid Disease
• Fibromuscular Dysplasia
• Lipedema
• Lymphedema
• May-Thurner Syndrome
• Metabolic Disease
• Metabolic Diseases
• Peripheral Arterial Disease
• Peripheral Artery Disease
• Syndrome
• Thoracic Outlet Syndrome
• Thrombosis
• Vasculitis
• Vasospasm
• Venous Disease

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To collect blood, urine, and/or stool samples for biorepository	To explore pathways of thrombosis, inflammation, gut microbiome, alterations in cell signaling, lipid metabolism and other metabolic pathways in vascular diseases	10 years