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

This study is currently recruiting participants.
Verified August 2012 by Columbia University
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

July 25, 2011
August 1, 2012
July 2011
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT01403142 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Optical Coherence Tomography (OCT) to Evaluate Cardiac Allograft Vasculopathy (CAV) in Patient's Post Heart Transplant
Optical Coherence Tomography to Evaluate Cardiac Allograft Vasculopathy in Patients Undergoing Clinically Indicated Angiographies Post Heart Transplant

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Post heart transplant

  • Cardiac Allograft Vasculopathy
  • Heart Transplant Recipients
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
January 2014
Not Provided

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.
Both
18 Years and older
No
Contact: Lauren Privitera 212-342-3488 lp2183@columbia.edu
Contact: Kate Dalton 212-305-7061 keb2114@columbia.edu
United States
 
NCT01403142
AAAI1023
No
Giora Weisz, Columbia University
Columbia University
Not Provided
Principal Investigator: Gioria Weisz, MD Columbia University
Columbia University
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP