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NCT05628974 Clinical Trial

Normal Donor Blood Draws for Platelet Studies and Biomarker Evaluation (ND-PLT)

Healthy Clinical Trial

— ND-PLT  

Official title:
Normal Donor Blood Draws for Platelet Studies and Biomarker Evaluation (ND-PLT)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05628974
Other study ID # 20-413
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 1, 2020
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
Health authority
Study type Observational

Clinical Trial Summary

This is a single-center study at the Cleveland Clinic Main Campus designed to study biomarkers in healthy individuals to identify novel mechanisms of platelet activation and how platelets drive vascular inflammation and thrombosis in diseases.

Description:

Our past studies have discovered novel platelet activation pathways that may be targets of therapeutic development. We have also defined an important role for a shift in platelet phenotype in vascular disease. Our studies use both in vivo animal models and validation using human platelets from isolated blood. Platelets from healthy individuals may be compared to patients with vascular diseases in the IRB approved protocol "Vascular Lab Resource" (IRB #19-1451) study which is actively recruiting patients at the Cleveland Clinic Main Campus and studies patients with vascular diseases.

Recruitment information / eligibility
Status Recruiting
Enrollment 400
Est. completion date June 30, 2031
Est. primary completion date December 31, 2030
Accepts healthy volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Adults aged 18 to 65 years old - Healthy Male & Female voluntary participants Exclusion Criteria: - Individuals who have taken anticoagulant or antiplatelet medications in past 10 days - Individuals with hematopoetic diseases

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Cleveland Clinic Cleveland Ohio

Sponsors (2)
Lead Sponsor Collaborator
The Cleveland Clinic National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (4)

Cameron SJ, Ture SK, Mickelsen D, Chakrabarti E, Modjeski KL, McNitt S, Seaberry M, Field DJ, Le NT, Abe J, Morrell CN. Platelet Extracellular Regulated Protein Kinase 5 Is a Redox Switch and Triggers Maladaptive Platelet Responses and Myocardial Infarct Expansion. Circulation. 2015 Jul 7;132(1):47-58. doi: 10.1161/CIRCULATIONAHA.115.015656. Epub 2015 May 1. — View Citation

Faraday N, Goldschmidt-Clermont PJ, Bray PF. Gender differences in platelet GPIIb-IIIa activation. Thromb Haemost. 1997 Apr;77(4):748-54. — View Citation

Hilt ZT, Pariser DN, Ture SK, Mohan A, Quijada P, Asante AA, Cameron SJ, Sterling JA, Merkel AR, Johanson AL, Jenkins JL, Small EM, McGrath KE, Palis J, Elliott MR, Morrell CN. Platelet-derived beta2M regulates monocyte inflammatory responses. JCI Insight. 2019 Mar 7;4(5):e122943. doi: 10.1172/jci.insight.122943. eCollection 2019 Mar 7. — View Citation

Schmidt RA, Morrell CN, Ling FS, Simlote P, Fernandez G, Rich DQ, Adler D, Gervase J, Cameron SJ. The platelet phenotype in patients with ST-segment elevation myocardial infarction is different from non-ST-segment elevation myocardial infarction. Transl Res. 2018 May;195:1-12. doi: 10.1016/j.trsl.2017.11.006. Epub 2017 Dec 2. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary To collect blood samples To establish a biorepository for normal healthy cohort of subjects 10 years
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