Cardiac Allograft Vasculopathy Clinical Trial
Official title:
Evaluation of Genomic, Structural and Molecular Changes Associated With Severe Cardiac Allograft Vasculopathy in Heart Transplant Recipients
Hypothesis: CAV is associated with fibrotic changes on cardiac MRI, altered levels of pathogenetically-related biomarkers, and specific RNA expression changes in the blood
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 2014 |
Est. primary completion date | May 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age = 18 years - Provide informed consent - Successful orthotopic heart transplant within 15 years of enrollment Exclusion Criteria: - Chronic kidney disease with creatinine >2.5 mg/dl - Ejection fraction <45% if CAV or <50% if no CAV - IV contrast allergy or reaction (gadolinium) - Active infection (febrile illness, cytomegalovirus or other significant infection) - Treated humoral rejection or cellular rejection grade 3A/2R or greater within 3 months - Contraindication to MRI |
Observational Model: Case Control, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
United States | University of Minnesota Medical Center | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
University of Minnesota - Clinical and Translational Science Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes from baseline associated with severe CAV | Determine the structural (degree of fibrosis), functional and genomic changes associated with severe CAV | 1 year | No |
Secondary | Novel noninvasive markers of CAV from baseline | Identify novel and noninvasive markers of CAV | 1 year | No |
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