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

This study has been completed.
Sponsor:
Collaborator:
St. Jude Medical
Information provided by (Responsible Party):
Amir Lerman, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01527344
First received: February 2, 2012
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

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.


Condition
Cardiac Allograft Vasculopathy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Assessment of Cardiac Allograft Vasculopathy With Optical Coherence Tomography as Compared to Intravascular Ultrasound-Virtual Histology

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Characterize CAV in-vivo with OCT [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compare the frequency and plaque type of CAV as defined with OCT versus IVUS-VH [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Predict the presence and severity of CAV with absolute counts of EPCs. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Predict the presence and severity of CAV with peripheral endothelial function scores [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 82
Study Start Date: August 2011
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
  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 Patients

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01527344

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
St. Jude Medical
Investigators
Principal Investigator: Amir Lerman, MD Cardiovascular Diseases, Professor of Medicine, Mayo Clinic Rochester
  More Information

No publications provided

Responsible Party: Amir Lerman, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01527344     History of Changes
Other Study ID Numbers: 11-003775
Study First Received: February 2, 2012
Last Updated: May 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
OCT
IVUS
CAV

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014