Dual Source CT Angiography for Detection of Coronary Artery Stenoses

N/AUnknownNCT01190579

University of Erlangen-Nürnberg Medical School398 enrolled

Overview

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%.

Study Type

OBSERVATIONAL

Enrollment

398

Conditions

Coronary Artery Disease

Eligibility

Sex: ALLMin age: 30 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (8)

Vejle Medical Center

Vejle, Denmark

RECRUITING

University of Erlangen

Erlangen, Germany

RECRUITING

Roentgenpraxis Hamburg

Hamburg, Germany

Outcomes

Primary Outcomes

Accuracy for the detection of coronary artery stenoses

Invasive coronary angiography will be preformed within 72 hours to verify coronary CT angiography results.

Time frame: 72 hours

Secondary Outcomes

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.

Time frame: 1 hour

Central Contacts

Stephan Achenbach, MD

CONTACT

++49 9131 8535000 stephan.achenbach@uk-erlangen.de

Dieter Ropers, MD

CONTACT

++49 9131 8535301 dieter.ropers@uk-erlangen.de

Data from ClinicalTrials.gov

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