Overview

This trial is active, not recruiting.

Condition aortic valve stenosis
Treatment low-volume, low-concentration contrast (iodixanol - visipaque 270) ct scan
Sponsor Medical University of South Carolina
Collaborator General Electric
Start date February 2013
End date December 2016
Trial size 40 participants
Trial identifier NCT01843426, Pro19770

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
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.
low-volume, low-concentration contrast (iodixanol - visipaque 270) ct scan
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.

Primary Outcomes

Measure
Clinically Diagnostic CT Assessments
time frame: up to 2 years

Secondary Outcomes

Measure
Image Quality
time frame: up to 2 years
Safety
time frame: up to 2 years
Long-term Follow-Up
time frame: up to 4 years

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

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.

Additional Information

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
Principal investigator Joseph Schoepf, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Medical University of South Carolina.