The Safety and toleRability of UltraviSt in Patients Unde... | NCT01206257

Studies
The Safety and toleRability of UltraviSt in Patients Undergoing Cardiac CaTheterization (TRUST)

NCT01206257

Sponsor

Bayer

Status

Completed

Last Update Posted

Jun 11, 2013Estimated

Enrollment

17,513Actual

Phase

Not provided

Conditions

Angiocardiography

Interventions

Iopromide (Ultravist, BAY86-4877)

Countries

China

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

ID	Type	Description	Link
UV1010CN	Other Identifier	company internal

Status Module

Record Verification Date

Jun 2013

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

Aug 2010

Primary Completion Date

Sep 2011Actual

Completion Date

Sep 2011Actual

First Submitted Date

Sep 20, 2010

First Submission Date that Met QC Criteria

Sep 20, 2010

First Posted Date

Sep 21, 2010Estimated

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

Jun 10, 2013

Last Update Posted Date

Jun 11, 2013Estimated

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

Description Module

Brief Summary

This study is to collect the information of Ultravist® in the patients indicated for the coronary angiography or PCI, like rate of ADR in patients, the dose for different indications, image quality to prove Ultravist the good safety and effectivity

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

17,513Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1			Drug: Iopromide (Ultravist, BAY86-4877)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Iopromide (Ultravist, BAY86-4877)	Drug	Intravenous/intraarterial digital subtraction angiography (DSA); Generally doses of up to 1.5 g iodine per kg body weight are well tolerated.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evaluation of the safety and tolerability of Ultravist® in patients Undergoing cardiac catheterization.		12 months

Secondary Outcomes

Measure	Description	Time Frame
Estimation of the image quality of Ultravist®		12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female and male patients who receive Ultravist® for coronary angiography or PCI can be included in the study

Exclusion Criteria:

Patients who are or are suspected in pregnancy or nursery
Patients with the contraindications for Ultravist
Patients with the contraindications for cardiac catheterization

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients who plan to undergo coronary angiography or PCI procedure with ultravist will be enrolled

Sampling Method

Probability Sample

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Intervention Browse Module

MeSH Terms

ID	Term
C038192	iopromide

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided