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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by University of Erlangen-Nürnberg Medical School.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Siemens Medical Solutions
Bayer
Information provided by:
University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT01190579
First received: August 20, 2010
Last updated: August 26, 2010
Last verified: August 2010
  Purpose

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
Coronary Artery Disease

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Erlangen-Nürnberg Medical School:

Primary Outcome Measures:
  • Accuracy for the detection of coronary artery stenoses [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    Invasive coronary angiography will be preformed within 72 hours to verify coronary CT angiography results.


Secondary Outcome Measures:
  • Safety of Ultravist 370 and Ultravist 300 for coronary CT angiography [ Time Frame: 1 hour ] [ Designated as safety issue: Yes ]
    Patients will be monitored for one hour after injection of Ultravist 370 and Ultravist 300 intravenously to assess safety and detect side effects.


Estimated Enrollment: 398
Study Start Date: August 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01190579

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

Locations
Denmark
Vejle Medical Center Recruiting
Vejle, Denmark
Contact: Kristian Ovrehus, MD         
Germany
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         
India
Ravi Bathina Recruiting
Hyderabad, India
Contact: Ravi Bathina, MD         
Mexico
Cardiovascular Institute Recruiting
Monterrey, Mexico
Contact: Erasmo De La Pena, MD         
Singapore
Tan Tok Seng Hospital Recruiting
Singapore, Singapore
Contact: Keng Thye Ho, MD         
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Siemens Medical Solutions
Bayer
Investigators
Principal Investigator: Stephan Achenbach, MD University of Erlangen-Nürnberg
  More Information

No publications provided

Responsible Party: Stephan Achenbach, University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT01190579     History of Changes
Other Study ID Numbers: MEDIC
Study First Received: August 20, 2010
Last Updated: August 26, 2010
Health Authority: Germany: Federal Office for Radiation Protection

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

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

ClinicalTrials.gov processed this record on October 29, 2014