Vascular Lab Resource (VLR) Biorepository

Vascular Lab Resource (VLR) Biorepository Study

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Lymphedema; Thrombosis; Vasculitis; Peripheral Artery Disease; Metabolic Disease; Lipedema; Thoracic Outlet Syndrome; Vasospasm; Venous Disease; Fibromuscular Dysplasia; May-Thurner Syndrome; Carotid Disease; Aneurysmal Disease; Non-Atherosclerotic Chronic Arterial Occlusive Disease; Arterial Dissection

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.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Scott Cameron, MD, PhD; Phone Number: 216-444-1680; Email: cameros3@ccf.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic
      • Contact: Scott Cameron, MD, PhD; Phone Number: 216-444-1680; Email: cameros3@ccf.org
      • Sub-Investigator: Stanley Hazen, MD
      • Sub-Investigator: Sean Lyden, MD
      • Sub-Investigator: Jerry Bartholomew, MD
      • Sub-Investigator: Natalia Fendrikova Mehlay, MD
      • Sub-Investigator: Keith McCrae, MD
      • Sub-Investigator: Rohan Bhandari, MD
      • Sub-Investigator: Dennis Bruemmer, MD
      • Sub-Investigator: Joanna Ghobrial, MD
      • Sub-Investigator: Vidyasagar Kalahasti, MD
      • Sub-Investigator: Lars Svensson, MD
      • Sub-Investigator: Peter Kaiser, MD
      • Sub-Investigator: Justis Ehlers, MD
      • Sub-Investigator: Pulkit Chaudhury, MD
      • Sub-Investigator: Sunil Srivastava, MD
      • Sub-Investigator: Leben Tefera, MD
      • Sub-Investigator: Douglas Joseph, DO
      • Sub-Investigator: Tamanna Singh, MD
      • Sub-Investigator: Anne Hubben, MD
      • Sub-Investigator: Mazen Hanna, MD
      • Sub-Investigator: Teresa Wu, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients who are with or at risk for cardiovascular or metabolic disease.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Scott Cameron, MD, PhD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2019
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): June 30, 2031

Study Registration Dates

• First Submitted: November 16, 2022
• First Submitted That Met QC Criteria: November 16, 2022
• First Posted (Actual): November 29, 2022

Study Record Updates

• Last Update Posted (Estimated): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Vascular Diseases; Neuromuscular Diseases; Connective Tissue Diseases; Peripheral Nervous System Diseases; Embolism and Thrombosis; Lymphatic Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Vascular Diseases; Aneurysm; Vascular Malformations; Nerve Compression Syndromes; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Nutritional and Metabolic Diseases; Skin and Connective Tissue Diseases; Hemic and Lymphatic Diseases; Dissection, Blood Vessel; Cardiovascular Diseases; Thrombosis; Lymphedema; Peripheral Arterial Disease; Metabolic Diseases; Vasculitis; Thoracic Outlet Syndrome; Fibromuscular Dysplasia; May-Thurner Syndrome; Lipedema
• Other Study ID Numbers: 19-1451

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No