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Noninvasive Predictors of Transplant Vasculopathy (CAV)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01424917
First received: March 22, 2011
Last updated: March 13, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition
Cardiac Allograft Vasculopathy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Noninvasive Predictors of Transplant Vasculopathy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Noninvasive measurement of endothelial function and presence of vasculopathy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    assess the association between various endothelial biomarkers and the presence or absence of transplant vasculopathy in patients after transplant


Estimated Enrollment: 100
Study Start Date: March 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Heart Transplant
Heart Transplant subjects

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Heart Transplant Subjects

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Chronic kidney disease stage 4 defined as GFR <30
  • Acute Rejection grade 3A or greater
  • Active Infection
  • Re-transplant
  • Multiorgan Transplant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01424917

Locations
United States, Minnesota
Cardiology Division, University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Monica Colvin-Adams, MD,MS Cardiology, University of Minnesota
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01424917     History of Changes
Other Study ID Numbers: 0802M27524
Study First Received: March 22, 2011
Last Updated: March 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Cardiac Allograft Vasculopathy

ClinicalTrials.gov processed this record on May 19, 2013