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Assessment of Cardiac Allograft Vasculopathy With Optical Coherence Tomography (CAV-OCT-IVUS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01527344
First Posted: February 7, 2012
Last Update Posted: May 9, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
St. Jude Medical
Information provided by (Responsible Party):
Amir Lerman, Mayo Clinic
February 2, 2012
February 7, 2012
May 9, 2014
August 2011
August 2013   (Final data collection date for primary outcome measure)
Characterize CAV in-vivo with OCT [ Time Frame: 1 year ]
To compare the frequency and plaque type of CAV as defined with OCT versus IVUS-Virtual Histology (IVUS-VH) [ Time Frame: 1 year ]
Complete list of historical versions of study NCT01527344 on ClinicalTrials.gov Archive Site
  • Compare the frequency and plaque type of CAV as defined with OCT versus IVUS-VH [ Time Frame: 1 year ]
  • Predict the presence and severity of CAV with absolute counts of EPCs. [ Time Frame: 1 year ]
  • Predict the presence and severity of CAV with peripheral endothelial function scores [ Time Frame: 1 year ]
  • To predict the presence and severity of CAV with absolute counts of EPCs. [ Time Frame: 1 year ]
  • To predict the presence and severity of CAV with peripheral endothelial function scores. [ Time Frame: 1 year ]
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Assessment of Cardiac Allograft Vasculopathy With Optical Coherence Tomography
Assessment of Cardiac Allograft Vasculopathy With Optical Coherence Tomography as Compared to Intravascular Ultrasound-Virtual Histology
Cardiac allograft vasculopathy (CAV) is a progressive disease of the coronary arteries in transplanted hearts which is a significant cause of morbidity and mortality. The broad objective of this research study is to advance our ability to diagnose as early as possible the presence of CAV and to non-invasively predict those patients at increased risk of CAV with novel techniques. Optical coherence tomography (OCT) is a novel intracoronary imaging technique using an optical analog of ultrasound with a resolution 10 times greater resolution than intravascular ultrasound (IVUS). Endothelial progenitor cells (EPCs) in peripheral blood have been shown to play a role in the pathogenesis of atherosclerosis and peripheral arterial tonometry is a clinical tool used to predict endothelial dysfunction (a precursor of atherosclerosis) which has been validated in non-transplant patients. Patients scheduled for routine cardiac catheterization with IVUS at the Mayo Clinic Rochester, Minnesota (MN) that reach inclusion and exclusion criteria for the study will be approached on the day to get informed consent to perform OCT, blood sampling and peripheral endothelial function testing. The investigators aim to 1) compare the frequency and plaque type of CAV as defined with OCT versus IVUS-Virtual Histology (IVUS-VH), 2) predict the presence and severity of CAV with absolute counts of EPCs and 3) with peripheral endothelial function scores.
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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample
Heart Transplant Patients
Cardiac Allograft Vasculopathy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
82
August 2013
August 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients aged 18 or older
  • patients with cardiac transplant undergoing routine CAV surveillance

Exclusion Criteria:

  • patients < 18 years old
  • patients with acute rejection
  • patients with active infection
  • patients with chronic renal insufficiency with a glomerular filtration rate (GFR) < 30ml/min
  • patients not able to give informed consent
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01527344
11-003775
Yes
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Amir Lerman, Mayo Clinic
Mayo Clinic
St. Jude Medical
Principal Investigator: Amir Lerman, MD Cardiovascular Diseases, Professor of Medicine, Mayo Clinic Rochester
Mayo Clinic
May 2014