An observational study in Cardiovascular Diseases, Metabolic Disease and Peripheral Artery Disease, sponsored by The Cleveland Clinic. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-19.
Sponsored by The Cleveland Clinic · Observational
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.
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.
5,368 studies on the registry are indexed under Cardiovascular Diseases; 939 are open to participants now.
This study's planned enrollment of 500 is close to the median of 506 across 1,572 observational studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →The Cleveland Clinic is the lead sponsor of 831 studies on the registry; 119 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 73 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients who are with or at risk for cardiovascular or metabolic disease.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Time frame: 10 years
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2019 (actual). Primary completion is estimated for Dec 2030, 133 months after the start.
Of 580 non-industry observational studies under Cardiovascular Diseases, half reached primary completion within 70 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 196. This study's planned 133 months is above that.
Counting every sponsor, half of 664 studies reached it within 61 months; a quarter within 24 and three quarters within 192.
Cardiovascular Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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