NCT01424917

Brief Summary

Post transplant vasculopathy is a major negative outcome in heart transplantation. Current methods of detection are highly invasive and pose a risk to transplant recipients. Noninvasive markers of endothelial function can be used to detect transplant vasculopathy. Endothelial biomarkers such as: endothelial nitric oxide synthase, vascular cellular adhesion molecules, intracellular adhesion molecules, endothelin-1, thromboplastin, circulating endothelial cells, uric acid, and C-reactive play a role in the pathophysiologic mechanism of vasculopathy. Therefore, the investigators would like to assess the association between various endothelial biomarkers and the presence or absence of transplant vasculopathy.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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 Start

First participant enrolled

March 1, 2008

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2011

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 29, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 25, 2017

Status Verified

January 1, 2017

Enrollment Period

5.8 years

First QC Date

March 22, 2011

Last Update Submit

January 23, 2017

Conditions

Cardiac Allograft Vasculopathy

Keywords

Cardiac Allograft Vasculopathy

Outcome Measures

Primary Outcomes (1)

  • Noninvasive measurement of endothelial function and presence of vasculopathy

    assess the association between various endothelial biomarkers and the presence or absence of transplant vasculopathy in patients after transplant

    1 year

Study Arms (1)

Heart Transplant

Heart Transplant subjects

Eligibility Criteria

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

Heart Transplant Subjects

You may qualify if:

  • Provide informed consent
  • Age 18 years and greater
  • Cardiac transplant recipients who have been transplanted for more than one year

You may not qualify if:

  • Chronic kidney disease stage 4 defined as GFR \<30
  • Acute Rejection grade 3A or greater
  • Active Infection
  • Re-transplant
  • Multiorgan Transplant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiology Division, University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Study Officials

  • Monica Colvin-Adams, MD,MS

    Cardiology, University of Minnesota

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2011

First Posted

August 29, 2011

Study Start

March 1, 2008

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

January 25, 2017

Record last verified: 2017-01

Locations

US(1)