NCT05628948

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
63mo left

Started Nov 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress56%
Nov 2019Jun 2031

Study Start

First participant enrolled

November 14, 2019

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 29, 2022

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2031

Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

11.1 years

First QC Date

November 16, 2022

Last Update Submit

December 15, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Genetic testing such including messenger RNA sequencing (mRNA-seq), DNA sequencing including whole exome sequencing and whole genome sequencing, and protein analysis may be performed

MeSH Terms

Conditions

Cardiovascular DiseasesMetabolic DiseasesPeripheral Arterial DiseaseThrombosisLymphedemaLipedemaVasculitisFibromuscular DysplasiaDissection, Blood VesselMay-Thurner SyndromeThoracic Outlet Syndrome

Condition Hierarchy (Ancestors)

Nutritional and Metabolic DiseasesAtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesPeripheral Vascular DiseasesEmbolism and ThrombosisLymphatic DiseasesHemic and Lymphatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAneurysmVascular MalformationsCardiovascular AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNerve Compression SyndromesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Scott Cameron, MD, PhD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Scott Cameron, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 16, 2022

First Posted

November 29, 2022

Study Start

November 14, 2019

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

June 30, 2031

Last Updated

December 19, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations