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European Cardio Computer Tomography Registry

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
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

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   (Adult, Senior)
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
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: NCT01197703

Locations
Germany
Kerckhoff Klinik GmbH
Bad Nauheim, Germany
Elisabeth Krankenhaus
Essen, Germany
Cardioangiologisches Centrum Bethanien
Frankfurt, Germany
Klinik am Eichert
Göppingen, Germany
Deutsches Herzzentrum München
München, Germany
Herzzentrum Bogenhausen
München, Germany
Klinikum Traunstein
Traunstein, Germany
Sponsors and Collaborators
Stiftung Institut fuer Herzinfarktforschung
Investigators
Study Chair: Stephan Achenbach, MD Universitätsklinikum Erlangen
  More Information

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 December 09, 2016