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

NCT01403142 | Completed

• 1 other identifier: AAAI1023
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiac Allograft Vasculopathy

Keywords

heart transplant; vasculopathy

Outcome Measures

Primary Outcomes (1)

• Oberservational study. There are no specific outcome measures

  prior to end of study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Post heart transplant

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (1)

• Dong L, Maehara A, Nazif TM, Pollack AT, Saito S, Rabbani LE, Apfelbaum MA, Dalton K, Moses JW, Jorde UP, Xu K, Mintz GS, Mancini DM, Weisz G. Optical coherence tomographic evaluation of transplant coronary artery vasculopathy with correlation to cellular rejection. Circ Cardiovasc Interv. 2014 Apr;7(2):199-206. doi: 10.1161/CIRCINTERVENTIONS.113.000949. Epub 2014 Apr 8.

  PMID: 24714488 DERIVED

MeSH Terms

Conditions

Vascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Tamim Nazif, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: July 25, 2011
• First Posted: July 27, 2011
• Study Start: August 18, 2011
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: August 31, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)