Dual Source CT Angiography for Detection of Coronary Artery Stenoses

Coronary Artery Disease Clinical Trial

— MEDIC  

Official title:

Multicenter Evaluation of Coronary Dual Source CT Angiography in Patients With Intermediate Risk of Coronary Artery Stenoses

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01190579
• Other study ID #: MEDIC
• Status: Recruiting
• Phase: N/A
• First received: August 20, 2010
• Last updated: August 26, 2010
• Start date: August 2009
• Est. completion date: December 2010

Study information

• Verified date: August 2010
• Source: University of Erlangen-Nürnberg Medical School
• Contact: Stephan Achenbach, MD
• Phone: ++49 9131 8535000
• Email: stephan.achenbach[@]uk-erlangen.de
• Is FDA regulated: No
• Health authority: Germany: Federal Office for Radiation Protection
• Study type: Observational

Clinical Trial 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%.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 398
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Stenosis
• Myocardial Ischemia

Locations

Country	Name	City	State
Denmark	Vejle Medical Center	Vejle
Germany	University of Erlangen	Erlangen
Germany	Roentgenpraxis Hamburg	Hamburg
Germany	Deutsches Herzzentrum Muenchen	Muenchen
Germany	Klinikum Grosshadern	Munich
India	Ravi Bathina	Hyderabad
Mexico	Cardiovascular Institute	Monterrey
Singapore	Tan Tok Seng Hospital	Singapore

Sponsors (3)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School	Bayer, Siemens Medical Solutions

Countries where clinical trial is conducted

Denmark,  Germany,  India,  Mexico,  Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes