Completed

Diagnostic Image Quality and Safety of Low-Volume, Low-Concentration, Iso-Osmolar Contrast Medium in the Computed Tomographic Workup of Patients Considered for TAVR

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What is being tested

Low-volume, low-concentration contrast (iodixanol - Visipaque 270) CT scan

Drug
Who is being recruted

Aortic Valve Disease+3

+ Cardiovascular Diseases

+ Heart Diseases

From 18 to 90 Years
See all eligibility criteria
How is the trial designed

Diagnostic Study

Interventional
Study Start: February 2013
See protocol details

Summary

Principal SponsorMedical University of South Carolina
Last updated: August 2, 2018
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Study start date: February 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01843426
Principal SponsorMedical University of South Carolina
Last updated: August 2, 2018
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 90 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Aortic Valve DiseaseCardiovascular DiseasesHeart DiseasesHeart Valve DiseasesVentricular Outflow ObstructionAortic Valve Stenosis

Criteria

Inclusion Criteria: Subject must be 18-90 years of age. Subject must have been referred for a clinically indicated CT prior to TAVR. Subject must provide written informed consent prior to any study-related procedures being performed. Subject must be willing to comply with all clinical study procedures. Exclusion Criteria: 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. Subject has an acute psychiatric disorder or is cognitively impaired. Subject is using or is dependent on substances of abuse. Subject is unwilling to comply with the requirements of the protocol. Subject has previously entered this study. Subject has an allergy against iodinated contrast agents. Subject is in acute unstable condition.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Medical University of South Carolina

Charleston, United StatesOpen Medical University of South Carolina in Google Maps
CompletedOne Study Center