NCT01206257

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17,513

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 2010

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

June 11, 2013

Status Verified

June 1, 2013

Enrollment Period

1.1 years

First QC Date

September 20, 2010

Last Update Submit

June 10, 2013

Conditions

Angiocardiography

Keywords

SurveyAngiographyADRImage quality

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the safety and tolerability of Ultravist® in patients Undergoing cardiac catheterization.

    12 months

Secondary Outcomes (1)

  • Estimation of the image quality of Ultravist®

    12 months

Study Arms (1)

Group 1

Drug: Iopromide (Ultravist, BAY86-4877)

Interventions

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.

Group 1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Many Locations, China

Location

MeSH Terms

Interventions

iopromide

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 20, 2010

First Posted

September 21, 2010

Study Start

August 1, 2010

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

June 11, 2013

Record last verified: 2013-06

Locations

CN(1)