Optical Coherence Tomography (OCT) to Evaluate Cardiac Allograft Vasculopathy (CAV) in Patient's Post Heart Transplant

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Columbia University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Giora Weisz, Columbia University
ClinicalTrials.gov Identifier:
NCT01403142
First received: July 25, 2011
Last updated: August 1, 2012
Last verified: August 2012
  Purpose

Cardiac allograft vasculopathy (CAV) is a unique form of accelerated plaque formation seen in the coronary arteries of patients who have received heart transplantation. It is a major cause of morbidity and mortality in patients after heart transplant. Little progress has been made in characterizing this disease process, with more sophisticated imaging allowing for more detailed analysis of CAV, superior stratification of transplant recipients is possible and earlier interventions can be performed if necessary to prevent mortality and graft loss.

Optical Coherence Tomography (OCT) is a novel imaging modality with much higher resolution then Intra-Vascular Ultrasound (IVUS). This study will involve examining patients post-heart transplant using this high-resolution imaging modality. It is currently the standard care for patients post-heart transplant to receive annual coronary angiograms with close follow up. Patients will be imaged using OCT at the time of their routine annual angiogram, and will be re-imaged one year later at the time of the next annual angiogram or earlier if clinically indicated. The study goal is to better characterize CAV in vivo with OCT imaging and to try to identify patterns of the disease, including intra-coronary risk assessment.


Condition Phase
Cardiac Allograft Vasculopathy
Heart Transplant Recipients
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Optical Coherence Tomography to Evaluate Cardiac Allograft Vasculopathy in Patients Undergoing Clinically Indicated Angiographies Post Heart Transplant

Resource links provided by NLM:


Further study details as provided by Columbia University:

Estimated Enrollment: 50
Study Start Date: July 2011
Estimated Study Completion Date: January 2014
  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

Post heart transplant

Criteria

Inclusion Criteria:

  • Post heart transplant patients
  • Patients presenting for their routine annual or clinically indicated coronary angiogram post-heart transplant. The decision for coronary angiogram will be made by the treating physician from the heart-failure-transplant team (not by the physician who will do the angiogram)
  • Clinically suspect or evidence of CAV in previous coronary angiogram
  • Age > 18
  • Written informed-consent obtained

Exclusion Criteria:

  • Any complications that occur during routine biopsy of the coronary arteries during the same cath-lab visit
  • Baseline renal failure with Cr > 1.8
  • Contraindication for anticoagulation
  • Any other condition that in the opinion of the investigators would alter the safety of participation, or interfere with the ability to adhere to study procedures.
  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: NCT01403142

Contacts
Contact: Lauren Privitera 212-342-3488 lp2183@columbia.edu
Contact: Kate Dalton 212-305-7061 keb2114@columbia.edu

Locations
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Lauren Privitera, MPH    212-305-7061    lp2183@columbia.edu   
Principal Investigator: Giora Weisz, MD         
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Gioria Weisz, MD Columbia University
  More Information

No publications provided by Columbia University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Giora Weisz, Associate Professor of Clinical Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT01403142     History of Changes
Other Study ID Numbers: AAAI1023
Study First Received: July 25, 2011
Last Updated: August 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
heart transplant
vasculopathy

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014