Coronary Artery Disease (CAD)CARYSMANCT04936867
The CArdiac Imaging RegistrY Study
An observational study of Coronary Artery Disease (CAD), run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
In this prospective longitudinal observational investigator-led single centre cohort study we will include patients undergoing cardio-CT for clinical reasons, to evaluate the role of cardio-CT terms of its diagnostic and prognostic value, as well as risk-benefit ratio. Particular aims include: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease (CAD)
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 25 Jul 2017to 1 Jan 2025
- How long will I take part?
- 5 Years
- 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: Adults referred to clinical cardiac computertomography imaging
Who may be able to join
- Adults (=/>18 years of age)
- Able to provide informed consent
- Clinical indication for cardio-CT in line with the latest clinical guidelines
Who cannot join
- standard contraindications to CT (in line with local roles and guidelines - please see Appendix)
- known allergy to iodinated contrast agent
- suspected acute kidney injury
- unstable hemodynamic status or arrhythmias
- suspected acute coronary syndrome
- manifest thyrotoxicosis
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute for experimental and translational cardiovascular imaging
Frankfurt am Main, Hesse, 60596
About this study
Official title: The CArdiac Imaging RegistrY Study: Computed ToMogrAphy for Risk Stratification and Diagnostic Safety
In this prospective longitudinal observational investigator-led single centre cohort study we will include patients undergoing cardio-CT for clinical reasons, to evaluate the role of cardio-CT terms of its diagnostic and prognostic value, as well as risk-benefit ratio.
Particular aims include:
- To determine the prevalence of CAD for age, gender, ethnicity relative to established risk models
- To determine associations between CAD severity and plaque type and:
- with traditional risk factors (arterial hypertension, diabetes, hypercholesterolemia, smoking)
- blood markers of increased cardiovascular risk
- To determine predictive associations of between CAD with outcome (endpoint definitions in appendix)
- To determine the risk-benefit ratio (number of subsequent interventions, complications, radiation exposure, late onset of cancer diseases, etc).
Read the detailed description
Particular aims include:
- To determine the prevalence of CAD for age, gender, ethnicity relative to established risk models
- To determine associations between CAD severity and plaque type and:
- with traditional risk factors (arterial hypertension, diabetes, hypercholesterolemia, smoking)
- blood markers of increased cardiovascular risk
- To determine predictive associations of between CAD with outcome (endpoint definitions in appendix)
- To determine the risk-benefit ratio (number of subsequent interventions, complications, radiation exposure, late onset of cancer diseases, etc).
- Conditions
- Coronary Artery Disease (CAD)
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
number of deaths
Measured: 2 year
Survival
number of deaths
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start25 Jul 2017
- Primary completion1 Jan 2025
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Disease (CAD)Studies 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
- 100 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valentina Puentmann, Johann Wolfgang Goethe University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04936867
- Sponsor's protocol ID
- CARYSMA Registry Study 466/16
- Acronym
- CARYSMA
- Status last verified
- Jan 2026
- First submitted
- 16 Jun 2021
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The CArdiac Imaging RegistrY Study: Computed ToMogrAphy for Risk Stratification and Diagnostic Safety
- ClinicalTrials.gov ID
- NCT04936867
- Acronym / sponsor ID
- CARYSMA / CARYSMA Registry Study 466/16
- Conditions
- Coronary Artery Disease (CAD)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- 25 Jul 2017 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 23 Jun 2021 (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.
In this prospective longitudinal observational investigator-led single centre cohort study we will include patients undergoing cardio-CT for clinical reasons, to evaluate the role of cardio-CT terms of its diagnostic and prognostic value, as well as risk-benefit ratio.
Particular aims include:
- To determine the prevalence of CAD for age, gender, ethnicity relative to established risk models
- To determine associations between CAD severity and plaque type and:
- with traditional risk factors (arterial hypertension, diabetes, hypercholesterolemia, smoking)
- blood markers of increased cardiovascular risk
- To determine predictive associations of between CAD with outcome (endpoint definitions in appendix)
- To determine the risk-benefit ratio (number of subsequent interventions, complications, radiation exposure, late onset of cancer diseases, etc).
Detailed description
Particular aims include:
- To determine the prevalence of CAD for age, gender, ethnicity relative to established risk models
- To determine associations between CAD severity and plaque type and:
- with traditional risk factors (arterial hypertension, diabetes, hypercholesterolemia, smoking)
- blood markers of increased cardiovascular risk
- To determine predictive associations of between CAD with outcome (endpoint definitions in appendix)
- To determine the risk-benefit ratio (number of subsequent interventions, complications, radiation exposure, late onset of cancer diseases, etc).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults referred to clinical cardiac computertomography imaging
Key inclusion criteria (3 listed)
- Adults (=/>18 years of age)
- Able to provide informed consent
- Clinical indication for cardio-CT in line with the latest clinical guidelines
Key exclusion criteria (6 listed)
- standard contraindications to CT (in line with local roles and guidelines - please see Appendix)
- known allergy to iodinated contrast agent
- suspected acute kidney injury
- unstable hemodynamic status or arrhythmias
- suspected acute coronary syndrome
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
Survival
Time frame: 2 year
number of deaths
Survival
Time frame: 5 year
number of deaths
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 6 Jan 2026.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Coronary Artery Disease (CAD), run by Johann Wolfgang Goethe University Hospital 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 3 inclusion and 6 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 6 Jan 2026. 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?
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?
Survival (time frame: 2 year). The study lists 2 primary outcomes in all. 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 6 Jan 2026.