Dual Source CT Angiography for Detection of Coronary Arte... | NCT01190579

Studies
Dual Source CT Angiography for Detection of Coronary Artery Stenoses

NCT01190579

Sponsor

University of Erlangen-Nürnberg Medical School

Status

Unknown status

Last Update Posted

Aug 27, 2010Estimated

Enrollment

398Estimated

Phase

Not provided

Conditions

Coronary Artery Disease

Interventions

Not provided

Countries

Denmark
Germany
India
Mexico
Singapore

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

Aug 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2009

Primary Completion Date

Dec 2010Estimated

Completion Date

Dec 2010Estimated

First Submitted Date

Aug 20, 2010

First Submission Date that Met QC Criteria

Aug 26, 2010

First Posted Date

Aug 27, 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

Aug 26, 2010

Last Update Posted Date

Aug 27, 2010Estimated

Name	Class
Siemens Medical Solutions	INDUSTRY
Bayer	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The trial will investigate the accuracy of Dual Source CT coronary angiography to detect coronary artery stenoses in patients with chest pain who have, based on clinical criteria, an intermediate likelihood for the presence of coronary artery stenoses. No beta blockers will be used to lower the heart rate for the examination. The hypothesis is that Dual Source CT will allow the detection of vessels with at least one coronary artery stenosis with a sensitivity of more than 90%.

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

398Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Accuracy for the detection of coronary artery stenoses	Invasive coronary angiography will be preformed within 72 hours to verify coronary CT angiography results.	72 hours

Secondary Outcomes

Measure	Description	Time Frame
Safety of Ultravist 370 and Ultravist 300 for coronary CT angiography	Patients will be monitored for one hour after injection of Ultravist 370 and Ultravist 300 intravenously to assess safety and detect side effects.	1 hour

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

suspected coronary artery disease
chest Pain
intermediate likelihood of coronary stenoses
planned invasive coronary angiography
age 30 to 80 years

Exclusion Criteria:

non sinus rhythm
contrast allergy
renal failure
unstable clinical condition
previous coronary revascularization
calcium score exceeding 800
inability to perform 10 second breathhold
possible pregnancy
metformin medication that cannot be interrupted
inability to establish antecubital iv access

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with Chest Pain and an Intermdiate Likelihood for Coronary Artery Stenoses

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Stephan Achenbach, MD	Contact	++49 9131 8535000		stephan.achenbach@uk-erlangen.de
Dieter Ropers, MD	Contact	++49 9131 8535301		dieter.ropers@uk-erlangen.de

Overall Officials

Name	Affiliation	Role
Stephan Achenbach, MD	University of Erlangen-Nürnberg	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vejle Medical Center	Recruiting	Vejle			Denmark

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease
D002637	Chest Pain

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided