Study Stopped
PI left University
Severe CAV MRI in Heart Transplant Recipient
Evaluation of Genomic, Structural and Molecular Changes Associated With Severe Cardiac Allograft Vasculopathy in Heart Transplant Recipients
1 other identifier
observational
N/A
1 country
1
Brief Summary
Hypothesis: CAV is associated with fibrotic changes on cardiac MRI, altered levels of pathogenetically-related biomarkers, and specific RNA expression changes in the blood
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2012
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 13, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedFirst Posted
Study publicly available on registry
May 19, 2016
CompletedMay 19, 2016
May 1, 2016
2 years
March 13, 2013
May 16, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Changes from baseline associated with severe CAV
Determine the structural (degree of fibrosis), functional and genomic changes associated with severe CAV
1 year
Secondary Outcomes (1)
Novel noninvasive markers of CAV from baseline
1 year
Eligibility Criteria
Heart transplant patients with severe CAV and heart transplant patients without CAV
You may qualify if:
- Age ≥ 18 years
- Provide informed consent
- Successful orthotopic heart transplant within 15 years of enrollment
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455, United States
Biospecimen
Blood samples will be saved in paxgene tubes for RNA sequencing
Study Officials
- PRINCIPAL INVESTIGATOR
Monica M Colvin-Adams, MD.,MS
University of Minnesota
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2013
First Posted
May 19, 2016
Study Start
May 1, 2012
Primary Completion
May 1, 2014
Study Completion
December 1, 2014
Last Updated
May 19, 2016
Record last verified: 2016-05