NCT05628974

Brief 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
63mo left

Started May 2020

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 Progress54%
May 2020Jun 2031

Study Start

First participant enrolled

May 1, 2020

Completed
2.5 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 16, 2025

Status Verified

December 1, 2025

Enrollment Period

10.7 years

First QC Date

November 16, 2022

Last Update Submit

December 15, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • To collect blood samples

    To establish a biorepository for normal healthy cohort of subjects

    10 years

Eligibility Criteria

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

Voluntary donors will be screened by questioning for use of anti-coagulant medications such as aspirin or other non-steroidal anti-inflammatory agents, in the past 10 days, or for hematopoietic diseases. Only healthy volunteers included as platelet donors.

You may qualify if:

  • Adults aged 18 to 65 years old
  • Healthy Male \& Female voluntary participants

You may not qualify if:

  • Individuals who have taken anticoagulant or antiplatelet medications in past 10 days
  • Individuals with hematopoetic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Related 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.

    PMID: 25934838BACKGROUND
  • 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.

    PMID: 29274308BACKGROUND
  • 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.

    PMID: 30702442BACKGROUND
  • Faraday N, Goldschmidt-Clermont PJ, Bray PF. Gender differences in platelet GPIIb-IIIa activation. Thromb Haemost. 1997 Apr;77(4):748-54.

    PMID: 9134654BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood

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

May 1, 2020

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

June 30, 2031

Last Updated

December 16, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations