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Noninvasive Predictors of Transplant Vasculopathy (CAV)

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ClinicalTrials.gov Identifier: NCT01424917
Recruitment Status : Withdrawn (Investigator Left university)
First Posted : August 29, 2011
Last Update Posted : January 25, 2017
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

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.

Condition or disease
Cardiac Allograft Vasculopathy

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Noninvasive Predictors of Transplant Vasculopathy
Study Start Date : March 2008
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Heart Transplant
Heart Transplant subjects



Primary Outcome Measures :
  1. Noninvasive measurement of endothelial function and presence of vasculopathy [ Time Frame: 1 year ]
    assess the association between various endothelial biomarkers and the presence or absence of transplant vasculopathy in patients after transplant



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01424917     History of Changes
Other Study ID Numbers: 0802M27524
First Posted: August 29, 2011    Key Record Dates
Last Update Posted: January 25, 2017
Last Verified: January 2017

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

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases