Dual Source CT Angiography for Detection of Coronary Artery Stenoses

• Conditions: Coronary Artery Disease

• Registration Number: NCT01190579
• Lead Sponsor: University of Erlangen-Nürnberg Medical School

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 available

Study Timeline

• Study Start: 2009-08
• Status Verified: 2010-08
• Study First Submitted: 2010-08-20
• Study First Submitted QC: 2010-08-26
• Last Update Submitted: 2010-08-26
• Study First Posted: 2010-08-27
• Last Update Posted: 2010-08-27
• Primary Completion: 2010-12
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 398

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (8)

Vejle Medical Center; 🇩🇰 Vejle, Denmark

University of Erlangen; 🇩🇪 Erlangen, Germany

Roentgenpraxis Hamburg; 🇩🇪 Hamburg, Germany

Deutsches Herzzentrum Muenchen; 🇩🇪 Muenchen, Germany

Klinikum Grosshadern; 🇩🇪 Munich, Germany

Ravi Bathina; 🇮🇳 Hyderabad, India

Cardiovascular Institute; 🇲🇽 Monterrey, Mexico

Tan Tok Seng Hospital; 🇸🇬 Singapore, Singapore