Detection of Pulmonary Embolism With CECT | NCT00351754

Studies
Detection of Pulmonary Embolism With CECT

NCT00351754

Sponsor

Bracco Diagnostics, Inc

Status

Completed

Last Update Posted

Jan 7, 2008Estimated

Enrollment

120

Phase

Phase 4

Conditions

Pulmonary Embolism

Interventions

Isovue

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

Jan 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2006

Primary Completion Date

Not provided

Completion Date

Nov 2006Actual

First Submitted Date

Jun 30, 2006

First Submission Date that Met QC Criteria

Jul 11, 2006

First Posted Date

Jul 13, 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

Jan 3, 2008

Last Update Posted Date

Jan 7, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120

Name	Type	Description	Arm Group Labels	Other Names
Isovue	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hounsfield Units (HU) measured at various levels of pulmonary arteries

Secondary Outcomes

Measure	Description	Time Frame
Presence of artifacts; global enhancement

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients 18 yrs or older
With suspected PE
Referred for MDCTA of pulmonary arteries
Signed informed consent

Exclusion Criteria:

Pregnant and lactating females
History of hypersensitivity to iodinated contrast agents
Hyperthyroidism or pheochromocytoma
Severe CHF
Renal impairment
Weight greater than 300 lbs
Pacemaker
Swan Ganz catheter
Defibrillator or other intrathoracic metallic vascular device
Received an investigational compound within 30 days of being in the study

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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Steve Sireci, M.D.	Bracco Diagnostics	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bracco Diagnostics, Inc.		Princeton	New Jersey	08540	United States

Condition Browse Module

MeSH Terms

ID	Term
D011655	Pulmonary Embolism

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D004617	Embolism
D016769	Embolism and Thrombosis

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007479	Iopamidol

Ancestor Terms

ID	Term
D014283	Triiodobenzoic Acids
D007463	Iodobenzoates
D001565	Benzoates
D000146	Acids, Carbocyclic

Browse Leaves

Not provided

Browse Branches

Not provided