Endothelial Function and Circulating Microparticle in Patients Under LVAD Support
MP-LVAD
1 other identifier
observational
65
1 country
1
Brief Summary
The aims of this project are 1) to evaluate whether circulating micraparticals (MPs) in patients with LVAD impair endothelial function and 2) to assess the procoagulative activity of circulating MPs in patients with LVAD in a prospective longitudinal study of patients undergoing LVAD implantation, 3) to analyze these parameters in the context of thromboembolic events.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2017
CompletedFirst Submitted
Initial submission to the registry
April 12, 2019
CompletedFirst Posted
Study publicly available on registry
April 22, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2019
CompletedJune 21, 2019
June 1, 2019
2.1 years
April 12, 2019
June 19, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Occurrence of thrombemboic events during 12 month
12 month
Secondary Outcomes (3)
Endothelial function
Baseline
Level of circulating mircoparticles
Baseline
microparticle induced thrombin generation
Baseline
Study Arms (2)
patients with chronic heart failure without LVAD support
patients with chronic heart failure without LVAD support
patients with end-stage heart failure with LVAD support
patients with end-stage heart failure with LVAD support
Interventions
Blood samples for MP evaluation
Eligibility Criteria
Patients in the heart failure program of the University of Duesseldorf
You may qualify if:
- Patients on LVAD support
You may not qualify if:
- current thrombembolic or bleeding event
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Heinrich-Heine-University, Div. of Cardiology, Pulmonary Disease and Vascular Medicine
Düsseldorf, North Rhine-Westphalia, 40225, Germany
Related Publications (1)
Kramser N, Oehler D, Saeed D, Aubin H, Akhyari P, Kelm M, Westenfeld R, Horn P. Thromboembolic Events in Patients With Left Ventricular Assist Devices Are Related to Microparticle-Induced Coagulation. ASAIO J. 2021 Jan 1;67(1):59-66. doi: 10.1097/MAT.0000000000001200.
PMID: 33346991DERIVED
Biospecimen
3ml venous blood
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.med. Patrick Horn, Principle Investigator
Study Record Dates
First Submitted
April 12, 2019
First Posted
April 22, 2019
Study Start
May 1, 2017
Primary Completion
May 31, 2019
Study Completion
May 31, 2019
Last Updated
June 21, 2019
Record last verified: 2019-06