Endothelial Microparticles: A Novel Marker of Vascular Dysfunction

NCT ID: NCT02230202

Last Updated: 2018-02-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2016-03-31

Brief Summary

The primary hypothesis of this proposal is that chronic kidney disease (CKD) and treatment with calcineurin inhibitors (CNIs) are each associated with the release of endothelial microparticles into the plasma.

Detailed Description

The primary hypothesis of this proposal is that chronic kidney disease (CKD) and treatment with calcineurin inhibitors (CNIs) are each associated with the release of endothelial microparticles into the plasma. These injury-associated microparticles have a different molecular/protein composition than those released from endothelial cells in healthy patients, and their abundance correlates with vascular injury. To test this hypothesis the investigators propose a 3 arm case-controlled study including normal controls, individuals with stage III and IV CKD not receiving CNI therapy, and individuals with stage III and IV CKD post kidney transplantation receiving a CNI. The goal of this study is to measure the amount of microparticles in patients with kidney disease who have had a kidney transplant. Another goal of this study is to see if the measurements of microparticles are related to poor function of the vessels (endothelial dysfunction).

Conditions

Chronic Kidney Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Healthy control

Healthy control that meets inclusion/exclusion criteria. Single blood draw and flow-mediated dilation (FMD).

Flow-mediated dilation

Intervention Type: OTHER

Flow-mediated dilation used to measure vascular function. The test is minimally invasive, with only a slight discomfort due to the inflation of the arm cuff.

single blood draw

Intervention Type: OTHER

single blood draw of approximately 45 mL.

Stage III or IV CKD patients

Stage III or IV CKD patients that meets inclusion/exclusion criteria. Single blood draw and flow-mediated dilation (FMD).

Flow-mediated dilation

Intervention Type: OTHER

Flow-mediated dilation used to measure vascular function. The test is minimally invasive, with only a slight discomfort due to the inflation of the arm cuff.

single blood draw

Intervention Type: OTHER

single blood draw of approximately 45 mL.

Post-transplant patients

Stage III or IV CKD Post-transplant patients that meets inclusion/exclusion criteria. Single blood draw and flow-mediated dilation (FMD).

Flow-mediated dilation

Intervention Type: OTHER

Flow-mediated dilation used to measure vascular function. The test is minimally invasive, with only a slight discomfort due to the inflation of the arm cuff.

single blood draw

Intervention Type: OTHER

single blood draw of approximately 45 mL.

Interventions

Flow-mediated dilation

Flow-mediated dilation used to measure vascular function. The test is minimally invasive, with only a slight discomfort due to the inflation of the arm cuff.

Intervention Type: OTHER

single blood draw

single blood draw of approximately 45 mL.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

For Healthy controls:

• BMI less than 40 kg/m^2
• Able to give informed consent

For Stage III or IV CKD patients:

• BMI less than 40 kg/m^2
• Able to give informed consent
• An estimated Glomerular-Filtration Rate (GFR) of 20-60 mL/min/1.73m^2

For Post-kidney transplant and stage III or IV CKD patients:

• BMI less than 40 kg/m^2
• Able to give informed consent
• An estimated Glomerular-Filtration Rate (GFR) of 20-60 mL/min/1.73m^2

Exclusion Criteria

For Healthy controls:

-Women pregnant or breastfeeding

For Stage III or IV CKD patients:

• Women pregnant or breastfeeding
• Adults with a life expectancy of less than one year
• A history of significant liver disease or congestive heart failure
• Hospitalization within the last three months
• Active infection on antibiotic therapy
• Uncontrolled hypertension (>140/90)
• Immunosuppressive therapy within the last year

For Post-transplant stage III or IV CKD patients:

• Women pregnant or breastfeeding
• Adults with a life expectancy of less than one year
• A history of significant liver disease or congestive heart failure
• Hospitalization within the last three months
• Active infection on antibiotic therapy
• Uncontrolled hypertension (>140/90)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joshua M Thurman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado Anschutz Medical Campus; CTRC

Aurora, Colorado, United States

University of Colorado School of Medicine

Aurora, Colorado, United States

Countries

United States

References

Jalal D, Renner B, Laskowski J, Stites E, Cooper J, Valente K, You Z, Perrenoud L, Le Quintrec M, Muhamed I, Christians U, Klawitter J, Lindorfer MA, Taylor RP, Holers VM, Thurman JM. Endothelial Microparticles and Systemic Complement Activation in Patients With Chronic Kidney Disease. J Am Heart Assoc. 2018 Jul 13;7(14):e007818. doi: 10.1161/JAHA.117.007818.

Reference Type: DERIVED

PMID: 30006493 (View on PubMed)

Other Identifiers

UL1TR001082

Identifier Type: NIH

Identifier Source: secondary_id

View Link

14-1209

Identifier Type: -

Identifier Source: org_study_id