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

Aortic Valve Stenosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01843426
• Other study ID #: Pro19770
• Status: Completed
• Phase: N/A
• Start date: February 2013
• Est. completion date: September 25, 2017

Study information

• Verified date: March 2018
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 25, 2017
• Est. primary completion date: September 25, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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 ßHCG) 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.

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	General Electric

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinically Diagnostic CT Assessments	Determine that restricting the contrast media volume to 60ml of 270 mgI/ml iodixanol or less generates clinically diagnostic CT assessments prior to TAVR.	up to 2 years
Secondary	Image Quality	Measure contrast media attenuation and determine diagnostic image quality within target structures in the aortic root and the ilio-aortic access route.	up to 2 years
Secondary	Safety	Evaluate safety and 30-day outcome of patients regarding survival, renal function, and adverse events (renal failure, dialysis, general morbidity).	up to 2 years
Secondary	Long-term Follow-Up	Determine procedural outcome of the TAVR procedure by longer-term patient follow-up after one and two years for device function, position, and paravalvular leakage.	up to 4 years