Brief Title
Aortic Stenosis Pre-Transcatheter Aortic Valve Replacement (TAVR) Procedure CT Scan
Official Title
Diagnostic Image Quality and Safety of Low-Volume, Low-Concentration, Iso-Osmolar Contrast Medium in the Computed Tomographic Workup of Patients Considered for TAVR
Brief Summary
The purpose of this study is to evaluate contrast media volume, safety and 30-day outcome of
patients after a computed tomography (CT) scan. The results of this study will help to
determine the minimum volume of contrast material that can be used to ensure patient safety
while not compromising diagnostic image quality in high-risk patients.
Detailed Description
The scholarly rationale for the study is to determine the feasibility of restricting the
contrast media volume to 60ml of 270mg Iodine (mgI)/ml iodixanol or less to accomplish
sufficient intravascular attenuation for comprehensive CT assessment prior to TAVR. The study
will also evaluate the effects of contrast media administration on our subjects' kidney
function by performing serum creatinine measurements at baseline, as well as at three days
and thirty days after contrast media administration.
Study Type
Interventional
Primary Outcome
Clinically Diagnostic CT Assessments
Secondary Outcome
Image Quality
Condition
Aortic Valve Stenosis
Intervention
Low-volume, low-concentration contrast (iodixanol - Visipaque 270) CT scan
Study Arms / Comparison Groups
Low-volume, Low-concentration contrast (Visipaque 270) CT scan
Description: An ECG-synchronized, contrast-medium enhanced CT study of the heart for the evaluation of the aortic root complex and general cardiac morphology will be obtained. This is immediately followed by a CT angiographic study of the chest, abdomen, and pelvis (beyond the femoral heads), which utilizes the same contrast bolus that is injected for evaluating the heart. This latter vascular study serves to evaluate the TAVR deployment catheter access route through the femoral, iliac, and aortic vascular stations. In clinical routine, we have been performing this type of study with total contrast media volumes ranging from 40-120 mL of iodinated contrast material.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
40
Start Date
February 2013
Completion Date
September 25, 2017
Primary Completion Date
September 25, 2017
Eligibility Criteria
Inclusion Criteria:
1. Subject must be 18-90 years of age.
2. Subject must have been referred for a clinically indicated CT prior to TAVR.
3. Subject must provide written informed consent prior to any study-related procedures
being performed.
4. Subject must be willing to comply with all clinical study procedures.
Exclusion Criteria:
1. Subject is a pregnant or nursing female. Exclude the possibility of pregnancy:
- By testing (serum or urine βHCG) within 24 hours before contrast agent
administration, or
- By surgical sterilization, or
- Post menopausal, with minimum one (1) year history without menses.
2. Subject has an acute psychiatric disorder or is cognitively impaired.
3. Subject is using or is dependent on substances of abuse.
4. Subject is unwilling to comply with the requirements of the protocol.
5. Subject has previously entered this study.
6. Subject has an allergy against iodinated contrast agents.
7. Subject is in acute unstable condition.
Gender
All
Ages
18 Years - 90 Years
Accepts Healthy Volunteers
No
Contacts
Joseph Schoepf, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01843426
Organization ID
Pro19770
Responsible Party
Sponsor
Study Sponsor
Medical University of South Carolina
Collaborators
General Electric
Study Sponsor
Joseph Schoepf, MD, Principal Investigator, Medical University of South Carolina
Verification Date
March 2018