Evaluation of CT in Coronary Artery StenosisNCT03815123
Register Kardialer Computertomographie
An observational study of Evaluation of CT in Coronary Artery Stenosis, run by Das Radiologische Zentrum at 1 site in Germany.
Trial summary
The aim of this Heidelberg Cardiac CT Registry (Register kardiale Computertomographie) is to assess the diagnostic and prognostic perfomance of cardiac CT exminations in a real-world patient population. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Evaluation of CT in Coronary Artery Stenosis
- What is being tested?
- cardiac CT
- How many people
- 10,000 participants
- Where
- 1 siteGermany
- Study dates
- 6 Dec 2018to Dec 2029
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Subjects referred for cardiac CT examination by their physician
Who may be able to join
- Subjects referred for cardiac CT examination by their physician
Who cannot join
- none
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Radiologische Praxis Heidelberg
Heidelberg, Baden-Wurttemberg, 69126
Johannes Goerich, Prof., +49 1703042496 ext. 01703042496, jgoerich@t-online.de
Sebastian J Buss, Prof., +49 6221 316930, prof.buss@das-radiologische-zentrum.de
About this study
The aim of this Heidelberg Cardiac CT Registry (Register kardiale Computertomographie) is to assess the diagnostic and prognostic perfomance of cardiac CT exminations in a real-world patient population.
Read the detailed description
Anthropometric data, medical history and results of the CT examinations are collected in a database in order to adressing various scientific questions.
- Being tested
- cardiac CT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac CTDiagnostic test
The cardiac CT examinations are indicated by the referring physician. The participation in this study has no influence on the further diagnostic and therapeutic regimen.
What is being measured
The primary outcome is the main question the study is designed to answer.
coronary CT angiography
Evaluation of degree of coronary artery stenosis
Measured: 10 years
coronary CT angiography
Assessment of coronary plaque composition
Measured: 10 years
Agreement with other imaging modalities
Agreement with other imaging modalities
Measured: 10 years
Occurence of MACE
Occurence of major adverse events
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2019
- Study start6 Dec 2018
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Evaluation of CT in Coronary Artery StenosisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Das Radiologische Zentrum
- Sponsor type
- University, hospital or other
- Collaborators
- Heidelberg University
- Responsible party
- Principal investigator, Johannes Görich, Das Radiologische Zentrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03815123
- Sponsor's protocol ID
- S-758/2018
- Status last verified
- Apr 2020
- First submitted
- 21 Jan 2019
- Last updated
- 27 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Andre F, Fortner P, Emami M, Seitz S, Brado M, Guckel F, Sokiranski R, Sommer A, Frey N, Gorich J, Buss SJ. Factors influencing the safety of outpatient coronary CT angiography: a clinical registry study. BMJ Open. 2022 Aug 8;12(8):e058304. doi: 10.1136/bmjopen-2021-058304.
PubMed 35940836
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Register Kardialer Computertomographie
- ClinicalTrials.gov ID
- NCT03815123
- Acronym / sponsor ID
- S-758/2018
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Das Radiologische ZentrumUniversity, hospital or other
- Collaborators
- Heidelberg University
- Study start
- 6 Dec 2018 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 24 Jan 2019 (actual)
- 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 aim of this Heidelberg Cardiac CT Registry (Register kardiale Computertomographie) is to assess the diagnostic and prognostic perfomance of cardiac CT exminations in a real-world patient population.
Detailed description
Anthropometric data, medical history and results of the CT examinations are collected in a database in order to adressing various scientific questions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects referred for cardiac CT examination by their physician
Key inclusion criteria (1 listed)
- Subjects referred for cardiac CT examination by their physician
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cardiac CTThe cardiac CT examinations are indicated by the referring physician. The participation in this study has no influence on the further diagnostic and therapeutic regimen. | Diagnostic test | – |
Primary outcome
coronary CT angiography
Time frame: 10 years
Evaluation of degree of coronary artery stenosis
coronary CT angiography
Time frame: 10 years
Assessment of coronary plaque composition
Agreement with other imaging modalities
Time frame: 10 years
Agreement with other imaging modalities
Occurence of MACE
Time frame: 10 years
Occurence of major adverse events
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2020.
- Derived from this study: PubMed 35940836Andre F, Fortner P, Emami M, Seitz S, Brado M, Guckel F, Sokiranski R, Sommer A, Frey N, Gorich J, Buss SJ. Factors influencing the safety of outpatient coronary CT angiography: a clinical registry study. BMJ Open. 2022 Aug 8;12(8):e058304. doi: 10.1136/bmjopen-2021-058304.
- WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Evaluation of CT in Coronary Artery Stenosis, run by Das Radiologische Zentrum at 1 site 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 1 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: looking for participants now, as of the sponsor's last update on 27 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Johannes Goerich, Prof. (+491703042496, jgoerich@t-online.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
coronary CT angiography (time frame: 10 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03815123, which also lists 1 linked publication.
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 27 Apr 2020.