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European Cardio Computer Tomography Registry

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Stiftung Institut fuer Herzinfarktforschung.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Stiftung Institut fuer Herzinfarktforschung
ClinicalTrials.gov Identifier:
NCT01197703
First received: September 7, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  Purpose

The European Cardiac CT Registry has the unique potential to provide important data that will help to clarify the clinical role of cardiac computed tomography (CT), to create guidelines and recommendations for its use, and to identify the most important areas that require specific further research.


Condition
Consecutive Patients Undergoing Computed Tomography of the Heart for Clinical Indications

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: European Cardio CT Registry

Resource links provided by NLM:

MedlinePlus related topics: CT Scans
U.S. FDA Resources

Further study details as provided by Stiftung Institut fuer Herzinfarktforschung:

Primary Outcome Measures:
  • collect data [ Time Frame: June 2009- ] [ Designated as safety issue: No ]
    The general aim of the Registry is to collect data from a large number of patients regarding the indications, general use, safety, and therapeutic implications of cardiac CT in European clinical practice.


Secondary Outcome Measures:
  • effect of coronary CT angiography [ Time Frame: June 2009- ] [ Designated as safety issue: No ]
    A first specific aim of the Registry is the analysis of the effect of coronary CT angiography on downstream resource utilization, revascularization procedures, and prognosis in patients with known or suspected coronary artery disease

  • analysis of radiation exposure during coronary CT angiography [ Time Frame: June 2009- ] [ Designated as safety issue: No ]
    The second specific aim is the analysis of radiation exposure during coronary CT angiography and the identification of parameters that influence radiation exposure, with the potential to provide specific guidance for interventions to lower radiation dose in the future


Estimated Enrollment: 20000
Study Start Date: June 2009
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All consecutive patients that are studies by computed tomography of the heart for clinical indications

Criteria

Inclusion Criteria:

  • Inclusion of all consecutive patients with accomplished or attempted CT imaging of the heart (whether imaging of the coronary arteries or other structures of the heart)
  • Informed consent to be entered in the registry.
  • Inclusion of all consecutive patients with accomplished or attempted coronary CT angiography.
  • Inclusion of all patients who undergo coronary CT angiography for clinical indications, with separate analysis of patients with suspected coronary artery disease and previously known coronary artery disease.

Exclusion Criteria:

- Besides the absence of informed consent, and cardiac CT studies performed as part of a research protocol, no exclusion criteria exist.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01197703

Contacts
Contact: Jochen Senges, MD 0621-503 ext 2801 senges@herzinfarktforschung.de

Locations
Germany
Kerckhoff Klinik GmbH Recruiting
Bad Nauheim, Germany
Contact: Thorsten Dill, MD            
Elisabeth Krankenhaus Recruiting
Essen, Germany
Contact: Oliver Bruder, MD            
Cardioangiologisches Centrum Bethanien Recruiting
Frankfurt, Germany
Contact: Axel Schmermund, MD            
Klinik am Eichert Recruiting
Göppingen, Germany
Contact: Stephen Schröder, MD            
Deutsches Herzzentrum München Recruiting
München, Germany
Contact: Jörg Hausleiter, MD            
Herzzentrum Bogenhausen Recruiting
München, Germany
Contact: Alexander Leber, MD            
Klinikum Traunstein Recruiting
Traunstein, Germany
Contact: Werner Moshage, MD            
Sponsors and Collaborators
Stiftung Institut fuer Herzinfarktforschung
Investigators
Study Chair: Stephan Achenbach, MD Universitätsklinikum Erlangen
  More Information

No publications provided

Responsible Party: Jochen Senges, MD, Institut für Herzinfarktforschung
ClinicalTrials.gov Identifier: NCT01197703     History of Changes
Other Study ID Numbers: Euro CT
Study First Received: September 7, 2010
Last Updated: September 7, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by Stiftung Institut fuer Herzinfarktforschung:
Clinical Practice Cardiac CT
Clinical Implications Coronary CT Angiography
Radiation Exposure of Coronary CT Angiography
Registry

ClinicalTrials.gov processed this record on May 23, 2013