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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01403142 |
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Date of registration:
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25/07/2011 |
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Primary sponsor: |
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Public title:
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Optical Coherence Tomography (OCT) to Evaluate Cardiac Allograft Vasculopathy (CAV) in Patient's Post Heart Transplant
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Scientific title:
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Optical Coherence Tomography to Evaluate Cardiac Allograft Vasculopathy in Patients Undergoing Clinically Indicated Angiographies Post Heart Transplant |
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Date of first enrolment:
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July 2011 |
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Target sample size:
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50 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01403142 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case-Only, Time Perspective: Prospective
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Countries of recruitment
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United States
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Contacts
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Name:
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Lauren Privitera, MPH |
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Address:
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Telephone:
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212-305-7061 |
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Email:
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lp2183@columbia.edu |
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Affiliation:
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Name:
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Lauren Privitera |
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Address:
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Telephone:
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212-342-3488 |
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Email:
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lp2183@columbia.edu |
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Affiliation:
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Name:
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Gioria Weisz, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Columbia University |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cardiac Allograft Vasculopathy
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Heart Transplant Recipients
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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