Safety and Effectiveness of Visipaque 320mg-I/ml for Use in Contrast-Enhanced CT Angiography of Arteries of the Heart

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Primary Purpose

Status

Terminated

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

iodixanol

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Coronary, Angiography, X-ray, CAD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subject is ≥18 years old. Subject must have been referred for an elective coronary angiography for one of several specified conditions. Exclusion Criteria: The subject has impaired renal function with a serum creatinine level ≥1.7 mg/dL (150 µmol/L). If the institution's practising guideline(s) regarding the serum creatinine limits for receiving radiologic contrast medium are lower than 1.7 mg/dL (150 µmol/L), the investigator should follow the practising guideline(s) of their institution. Subject has a known allergy to iodinated contrast agent Subject has atrial fibrillation/flutter or any irregular heart rhythm considered to interfere with temporal acquisition of cardiac CT images. The subject's resting heart rate is 66-100 bpm and β-blocker therapy is contraindicated. Use of nitroglycerin is contraindicated. Subject has had a prior CABG procedure. Subject has a metal cardiac stent in place or artificial heart valve(s). Subject has had a prior pacemaker or internal defibrillator lead implantation. Subject must agree to discontinue metformin day of and for 48 hours after the CTA procedure.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Visipaque Injection

Arm Description

All participants will receive intravenous (IV) administration of 80 mL Visipaque (iodixanol) 320 mg-I/mL at a rate of 4-5 mL per second via power injector followed by a saline injection of 40-50 mL 0.9% sodium chloride solution at a rate of 4-5 mL per second.

Outcomes

Primary Outcome Measures

To evaluate diagnostic performance and safety of Visipaque-enhanced CTA images for determination of presence or absence of coronary artery obstruction

Secondary Outcome Measures

Full Information

NCT ID

NCT00335335

First Posted

June 7, 2006

Last Updated

April 24, 2019

Sponsor

GE Healthcare

1. Study Identification

Unique Protocol Identification Number

NCT00335335

Brief Title

Safety and Effectiveness of Visipaque 320mg-I/ml for Use in Contrast-Enhanced CT Angiography of Arteries of the Heart

Official Title

Phase 3, Open-label, Multicenter Studies to Determine Efficacy and Safety of VISIPAQUETM (Iodixanol) Injection for Use in Intravenous Contrast-Enhanced CT Angiography of Coronary Arteries

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Terminated

Why Stopped

Sponsor decision due to low subject recrcuitment

Study Start Date

May 2006 (undefined)

Primary Completion Date

December 2, 2006 (Actual)

Study Completion Date

December 2, 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GE Healthcare

4. Oversight

5. Study Description

Brief Summary

CT (computed tomography) angiography (CTA) is an examination similar to a CAT scan that uses x-rays and a contrast medium (also called dye) to visualize blood flow in arteries and veins throughout the body. VISIPAQUE™ will be given through a vein in the arm before having the CTA scan of the heart arteries. The pictures it produces of the heart and its blood vessels will be reviewed and compared to those obtained during the catheter-based coronary angiography to see if the CTA shows the same blockages.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

Keywords

Coronary, Angiography, X-ray, CAD

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

89 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Visipaque Injection

Arm Type

Experimental

Arm Description

All participants will receive intravenous (IV) administration of 80 mL Visipaque (iodixanol) 320 mg-I/mL at a rate of 4-5 mL per second via power injector followed by a saline injection of 40-50 mL 0.9% sodium chloride solution at a rate of 4-5 mL per second.

Intervention Type

Drug

Intervention Name(s)

iodixanol

Other Intervention Name(s)

Visipaque

Primary Outcome Measure Information:

Title

To evaluate diagnostic performance and safety of Visipaque-enhanced CTA images for determination of presence or absence of coronary artery obstruction

Time Frame

48 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Subject is ≥18 years old. Subject must have been referred for an elective coronary angiography for one of several specified conditions. Exclusion Criteria: The subject has impaired renal function with a serum creatinine level ≥1.7 mg/dL (150 µmol/L). If the institution's practising guideline(s) regarding the serum creatinine limits for receiving radiologic contrast medium are lower than 1.7 mg/dL (150 µmol/L), the investigator should follow the practising guideline(s) of their institution. Subject has a known allergy to iodinated contrast agent Subject has atrial fibrillation/flutter or any irregular heart rhythm considered to interfere with temporal acquisition of cardiac CT images. The subject's resting heart rate is 66-100 bpm and β-blocker therapy is contraindicated. Use of nitroglycerin is contraindicated. Subject has had a prior CABG procedure. Subject has a metal cardiac stent in place or artificial heart valve(s). Subject has had a prior pacemaker or internal defibrillator lead implantation. Subject must agree to discontinue metformin day of and for 48 hours after the CTA procedure.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Veronica Reichl

Organizational Affiliation

GE Healthcare

Official's Role

Study Director

Facility Information:

City

Princeton

State/Province

New Jersey

ZIP/Postal Code

08540

Country

United States

Coronary Artery Disease

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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