Dual Source CT Angiography for Detection of Coronary Artery Stenoses

NCT ID: NCT01190579

Last Updated: 2010-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

398 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-12-31

Brief Summary

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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

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Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Siemens Medical Solutions

INDUSTRY

Sponsor Role collaborator

Bayer

INDUSTRY

Sponsor Role collaborator

University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role lead

Responsible Party

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University of Erlangen-Nürnberg Medical School

Principal Investigators

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Stephan Achenbach, MD

Role: PRINCIPAL_INVESTIGATOR

University of Erlangen-Nürnberg

Locations

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Vejle Medical Center

Vejle, , Denmark

Site Status RECRUITING

University of Erlangen

Erlangen, , Germany

Site Status RECRUITING

Roentgenpraxis Hamburg

Hamburg, , Germany

Site Status RECRUITING

Klinikum Grosshadern

Munich, , Germany

Site Status NOT_YET_RECRUITING

Deutsches Herzzentrum Muenchen

München, , Germany

Site Status RECRUITING

Ravi Bathina

Hyderabad, , India

Site Status RECRUITING

Cardiovascular Institute

Monterrey, , Mexico

Site Status RECRUITING

Tan Tok Seng Hospital

Singapore, , Singapore

Site Status RECRUITING

Countries

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Denmark Germany India Mexico Singapore

Central Contacts

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Stephan Achenbach, MD

Role: CONTACT

++49 9131 8535000

Dieter Ropers, MD

Role: CONTACT

++49 9131 8535301

Facility Contacts

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Kristian Ovrehus, MD

Role: primary

Stephan Achenbach, MD

Role: primary

++49 9131 8535000

Joern Sandstede

Role: primary

Christoph Becker, MD

Role: primary

Joerg Hausleiter, MD

Role: primary

Ravi Bathina, MD

Role: primary

Erasmo De La Pena, MD

Role: primary

Keng Thye Ho, MD

Role: primary

Other Identifiers

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MEDIC

Identifier Type: -

Identifier Source: org_study_id

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