Dual Source CT Angiography for Detection of Coronary Artery Stenoses

NCT01190579 | Unknown DMC

• 1 other identifier: MEDIC
• Study Type: observational
• Target: 398
• Locations: 5 countries
• Sites: 8

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%.

Conditions

Coronary Artery Disease

Keywords

Coronary Artery Disease; Chest Pain; Computed Tomography

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• Safety of Ultravist 370 and Ultravist 300 for coronary CT angiography

  1 hour

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead
• Siemens Medical Solutions: collaborator
• Bayer: collaborator

Study Sites (8)

Vejle Medical Center

Vejle, Denmark

RECRUITING

University of Erlangen

Erlangen, Germany

RECRUITING

Roentgenpraxis Hamburg

Hamburg, Germany

RECRUITING

Klinikum Grosshadern

Munich, Germany

NOT YET RECRUITING

Deutsches Herzzentrum Muenchen

München, Germany

RECRUITING

Ravi Bathina

Hyderabad, India

RECRUITING

Cardiovascular Institute

Monterrey, Mexico

RECRUITING

Tan Tok Seng Hospital

Singapore, Singapore

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Chest Pain

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephan Achenbach, MD

  University of Erlangen-Nürnberg

  PRINCIPAL INVESTIGATOR

Central Study 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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 20, 2010
• First Posted: August 27, 2010
• Study Start: August 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: August 27, 2010

Record last verified: 2010-08

Locations

IN (1); ME (1); SG (1); DK (1); DE (4)