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

August 26, 2010 updated by: University of Erlangen-Nürnberg Medical School

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

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%.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

398

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Vejle, Denmark
        • Recruiting
        • Vejle Medical Center
        • Contact:
          • Kristian Ovrehus, MD
  • Germany
      • Erlangen, Germany
        • Recruiting
        • University of Erlangen
        • Contact:
        • Principal Investigator:
          • Stephan Achenbach, MD
      • Hamburg, Germany
        • Recruiting
        • Roentgenpraxis Hamburg
        • Contact:
          • Joern Sandstede
      • Muenchen, Germany
        • Recruiting
        • Deutsches Herzzentrum Muenchen
        • Contact:
        • Principal Investigator:
          • Joerg Hausleiter, MD
      • Munich, Germany
        • Not yet recruiting
        • Klinikum Großhadern
        • Contact:
          • Christoph Becker, MD
  • India
      • Hyderabad, India
        • Recruiting
        • Ravi Bathina
        • Contact:
          • Ravi Bathina, MD
  • Mexico
      • Monterrey, Mexico
        • Recruiting
        • Cardiovascular Institute
        • Contact:
          • Erasmo De La Pena, MD
  • Singapore
      • Singapore, Singapore
        • Recruiting
        • Tan Tok Seng Hospital
        • Contact:
          • Keng Thye Ho, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Erlangen-Nürnberg Medical School

Collaborators

Bayer
Siemens Medical Solutions

Investigators

  • Principal Investigator: Stephan Achenbach, MD, University of Erlangen-Nürnberg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Anticipated)

December 1, 2010

Study Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

August 20, 2010

First Submitted That Met QC Criteria

August 26, 2010

First Posted (Estimate)

August 27, 2010

Study Record Updates

Last Update Posted (Estimate)

August 27, 2010

Last Update Submitted That Met QC Criteria

August 26, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEDIC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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