Aortic Stenosis Pre-Transcatheter Aortic Valve Replacement (TAVR) Procedure CT Scan

NCT ID: NCT01843426

Last Updated: 2018-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2017-09-25

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.

Conditions

Aortic Valve Stenosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Low-volume, Low-concentration contrast (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.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

General Electric

INDUSTRY

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph Schoepf, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Other Identifiers

Pro19770

Identifier Type: -

Identifier Source: org_study_id