- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01197703
European Cardio Computer Tomography Registry
March 13, 2017 updated by: Stiftung Institut fuer Herzinfarktforschung
European Cardio CT Registry
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.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
7115
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
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-
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Bad Nauheim, Germany
- Kerckhoff Klinik GmbH
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Essen, Germany
- Elisabeth Krankenhaus
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Frankfurt, Germany
- Cardioangiologisches Centrum Bethanien
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Göppingen, Germany
- Klinik am Eichert
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München, Germany
- Deutsches Herzzentrum München
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München, Germany
- Herzzentrum Bogenhausen
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Traunstein, Germany
- Klinikum Traunstein
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All consecutive patients that are studies by computed tomography of the heart for clinical indications
Description
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.
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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collect data
Time Frame: June 2009-
|
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.
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June 2009-
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
effect of coronary CT angiography
Time Frame: June 2009-
|
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
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June 2009-
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analysis of radiation exposure during coronary CT angiography
Time Frame: June 2009-
|
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
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June 2009-
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Stephan Achenbach, MD, Universitätsklinikum Erlangen
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 (Actual)
June 1, 2010
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
September 7, 2010
First Submitted That Met QC Criteria
September 7, 2010
First Posted (Estimate)
September 9, 2010
Study Record Updates
Last Update Posted (Actual)
March 14, 2017
Last Update Submitted That Met QC Criteria
March 13, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Euro CT
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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