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NCT01403142 · ClinicalTrials.gov registry record

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

A clinical trial of Cardiac Allograft Vasculopathy, sponsored by Columbia University.

Completed
Registry status
60
Enrollment target
1
Study location

NCT01403142: Completed study of Cardiac Allograft Vasculopathy, sponsored by Columbia University.

NCT01403142 is a study of Cardiac Allograft Vasculopathy that has completed, run by Columbia University. The registered enrollment target is 60 participants, below the 111-participant average among 3 other Cardiac Allograft Vasculopathy trials with a reported enrollment target (46% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01403142, a study of Cardiac Allograft Vasculopathy, has completed, sponsored by Columbia University.

COMPLETED
Registry status
60 participants
Enrollment target
1
Study location

Study 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.

Study Locations (1)

New York

  • Columbia University Medical Center - New York

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2011-08-18
Est. Completion 2017-01
Columbia University

958 total trials

What the finished NCT01403142 record still lists

NCT01403142 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 111-participant average among 3 other Cardiac Allograft Vasculopathy trials with a reported enrollment target (46% lower).

The record links to 1 condition, with Cardiac Allograft Vasculopathy appearing as the primary indexed condition, and to 0 interventions.

NCT01403142 reports a single indexed study location in New York.

Frequently Asked Questions

What is clinical trial NCT01403142 about?

NCT01403142 is a clinical study titled "Optical Coherence Tomography (OCT) to Evaluate Cardiac Allograft Vasculopathy (CAV) in Patient's 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 ...

What is the current status of trial NCT01403142?

This trial is currently completed. The enrollment target is 60 participants. The study started on 2011-08-18. Estimated completion is 2017-01.

What conditions does trial NCT01403142 study?

This clinical trial studies the following conditions: Cardiac Allograft Vasculopathy.

Who is sponsoring clinical trial NCT01403142?

This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01403142 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT01403142, the US trial registry maintained by the National Library of Medicine. NCT01403142 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.