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Dual Source CT Angiography for Detection of Coronary Artery Stenoses (MEDIC)

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ClinicalTrials.gov Identifier: NCT01190579
Recruitment Status : Unknown
Verified August 2010 by University of Erlangen-Nürnberg Medical School.
Recruitment status was:  Recruiting
First Posted : August 27, 2010
Last Update Posted : August 27, 2010
Information provided by:

Study Description
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%.

Condition or disease
Coronary Artery Disease

Study Design

Study Type : Observational
Estimated Enrollment : 398 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicenter Evaluation of Coronary Dual Source CT Angiography in Patients With Intermediate Risk of Coronary Artery Stenoses
Study Start Date : August 2009
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2010
Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. Accuracy for the detection of coronary artery stenoses [ Time Frame: 72 hours ]
    Invasive coronary angiography will be preformed within 72 hours to verify coronary CT angiography results.

Secondary Outcome Measures :
  1. Safety of Ultravist 370 and Ultravist 300 for coronary CT angiography [ Time Frame: 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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Chest Pain and an Intermdiate Likelihood for Coronary Artery Stenoses

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01190579

Contact: Stephan Achenbach, MD ++49 9131 8535000 stephan.achenbach@uk-erlangen.de
Contact: Dieter Ropers, MD ++49 9131 8535301 dieter.ropers@uk-erlangen.de

Vejle Medical Center Recruiting
Vejle, Denmark
Contact: Kristian Ovrehus, MD         
University of Erlangen Recruiting
Erlangen, Germany
Contact: Stephan Achenbach, MD    ++49 9131 8535000    stephan.achenbach@uk-erlangen.de   
Principal Investigator: Stephan Achenbach, MD         
Roentgenpraxis Hamburg Recruiting
Hamburg, Germany
Contact: Joern Sandstede         
Deutsches Herzzentrum Muenchen Recruiting
Muenchen, Germany
Contact: Joerg Hausleiter, MD       joerg.hausleiter@dhm.mhn.de   
Principal Investigator: Joerg Hausleiter, MD         
Klinikum Grosshadern Not yet recruiting
Munich, Germany
Contact: Christoph Becker, MD         
Ravi Bathina Recruiting
Hyderabad, India
Contact: Ravi Bathina, MD         
Cardiovascular Institute Recruiting
Monterrey, Mexico
Contact: Erasmo De La Pena, MD         
Tan Tok Seng Hospital Recruiting
Singapore, Singapore
Contact: Keng Thye Ho, MD         
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Siemens Medical Solutions
Principal Investigator: Stephan Achenbach, MD University of Erlangen-Nürnberg
More Information

Responsible Party: Stephan Achenbach, University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT01190579     History of Changes
Other Study ID Numbers: MEDIC
First Posted: August 27, 2010    Key Record Dates
Last Update Posted: August 27, 2010
Last Verified: August 2010

Keywords provided by University of Erlangen-Nürnberg Medical School:
Coronary Artery Disease
Chest Pain
Computed Tomography

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Coronary Stenosis
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases