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NCT Number: NCT05628948

Vascular Lab Resource (VLR) Biorepository

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location status: Recruiting

Location contact

Anne Hubben, MD

SUB_INVESTIGATOR

Dennis Bruemmer, MD

SUB_INVESTIGATOR

Douglas Joseph, DO

SUB_INVESTIGATOR

Jerry Bartholomew, MD

SUB_INVESTIGATOR

Joanna Ghobrial, MD

SUB_INVESTIGATOR

Justis Ehlers, MD

SUB_INVESTIGATOR

Keith McCrae, MD

SUB_INVESTIGATOR

Lars Svensson, MD

SUB_INVESTIGATOR

Leben Tefera, MD

SUB_INVESTIGATOR

Mazen Hanna, MD

SUB_INVESTIGATOR

Natalia Fendrikova Mehlay, MD

SUB_INVESTIGATOR

Peter Kaiser, MD

SUB_INVESTIGATOR

Pulkit Chaudhury, MD

SUB_INVESTIGATOR

Rohan Bhandari, MD

SUB_INVESTIGATOR

Scott Cameron, MD, PhD

CONTACT

[email protected]

216-444-1680

Sean Lyden, MD

SUB_INVESTIGATOR

Stanley Hazen, MD

SUB_INVESTIGATOR

Sunil Srivastava, MD

SUB_INVESTIGATOR

Tamanna Singh, MD

SUB_INVESTIGATOR

Teresa Wu, MD

SUB_INVESTIGATOR

Vidyasagar Kalahasti, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. To collect blood, urine, and/or stool samples for biorepository

    Time frame: 10 years

    To explore pathways of thrombosis, inflammation, gut microbiome, alterations in cell signaling, lipid metabolism and other metabolic pathways in vascular diseases

Study contacts

Contact information is provided by the study sponsor or research team.

Scott Cameron, MD, PhD

CONTACT

[email protected]

216-444-1680

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

Vascular Lab Resource (VLR) Biorepository Study

Important dates

Study start
2019
Primary completion
2030
Study completion
2031
First posted
Nov 29, 2022
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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