Safety and Effectiveness of Visipaque 320mg-I/ml for Use... | NCT00335335

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

NCT00335335

Sponsor

GE Healthcare

Status

Terminated

Last Update Posted

Apr 25, 2019Actual

Enrollment

89Actual

Phase

Phase 3

Conditions

Coronary Artery Disease

Interventions

iodixanol

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor decision due to low subject recrcuitment

Expanded Access Info

Start Date

May 2006

Primary Completion Date

Dec 2, 2006Actual

Completion Date

Dec 2, 2006Actual

First Submitted Date

Jun 7, 2006

First Submission Date that Met QC Criteria

Jun 7, 2006

First Posted Date

Jun 9, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 24, 2019

Last Update Posted Date

Apr 25, 2019Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

89Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Visipaque Injection	Experimental	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.	Drug: iodixanol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
iodixanol	Drug		Visipaque Injection	Visipaque

Measure	Description	Time Frame
To evaluate diagnostic performance and safety of Visipaque-enhanced CTA images for determination of presence or absence of coronary artery obstruction		48 hours

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases