Consecutive Patients Undergoing Computed Tomography of the Heart for Clinical IndicationsNCT01197703
European Cardio Computer Tomography Registry
An observational study of Consecutive Patients Undergoing Computed Tomography of the Heart for Clinical Indications, run by Stiftung Institut fuer Herzinfarktforschung at 7 sites in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Consecutive Patients Undergoing Computed Tomography of the Heart for Clinical Indications
- How many people
- 7,115 participants
- Where
- 7 sitesGermany
- Study dates
- Jun 2010to Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive patients that are studies by computed tomography of the heart for clinical indications
Who may be able to join
- 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.
Who cannot join
- Besides the absence of informed consent, and cardiac CT studies performed as part of a research protocol, no exclusion criteria exist.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Germany7 sites
Kerckhoff Klinik GmbH
Bad Nauheim
Elisabeth Krankenhaus
Essen
Cardioangiologisches Centrum Bethanien
Frankfurt
Klinik am Eichert
Göppingen
Deutsches Herzzentrum München
München
Herzzentrum Bogenhausen
München
Klinikum Traunstein
Traunstein
About this study
Official title: 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.
- Keywords
- Clinical Practice Cardiac CT, Clinical Implications Coronary CT Angiography, Radiation Exposure of Coronary CT Angiography, Registry
What is being measured
The primary outcome is the main question the study is designed to answer.
collect data
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.
Measured: June 2009-
Secondary outcomes (2)
effect of coronary CT angiography
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
Measured: June 2009-
analysis of radiation exposure during coronary CT angiography
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
Measured: June 2009-
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Consecutive Patients Undergoing Computed Tomography of the Heart for Clinical IndicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 7,115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stiftung Institut fuer Herzinfarktforschung
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephan Achenbach, MD, Study chair, University of Erlangen-Nürnberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01197703
- Sponsor's protocol ID
- Euro CT
- Status last verified
- Mar 2017
- First submitted
- 7 Sep 2010
- Last updated
- 14 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Cardio CT Registry
- ClinicalTrials.gov ID
- NCT01197703
- Acronym / sponsor ID
- Euro CT
- Keywords
- Clinical Practice Cardiac CT, Clinical Implications Coronary CT Angiography, Radiation Exposure of Coronary CT Angiography, Registry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,115 participants (actual)
- Lead sponsor
- Stiftung Institut fuer HerzinfarktforschungUniversity, hospital or other
- Study start
- Jun 2010 (actual)
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 9 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients that are studies by computed tomography of the heart for clinical indications
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Besides the absence of informed consent, and cardiac CT studies performed as part of a research protocol, no exclusion criteria exist.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
effect of coronary CT angiography
Time frame: June 2009-
analysis of radiation exposure during coronary CT angiography
Time frame: June 2009-
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephan Achenbach, MD study chair
University of Erlangen-Nürnberg
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Consecutive Patients Undergoing Computed Tomography of the Heart for Clinical Indications, run by Stiftung Institut fuer Herzinfarktforschung at 7 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
collect data (time frame: June 2009-). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2017.