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NCT Number: NCT04936867

The CArdiac Imaging RegistrY Study

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. To determine the prevalence of CAD for age, gender, ethnicity relative to established risk models 2. To determine associations between CAD severity and plaque type and:

1. with traditional risk factors (arterial hypertension, diabetes, hypercholesterolemia, smoking) 2. blood markers of increased cardiovascular risk 3. To determine predictive associations of between CAD with outcome (endpoint definitions in appendix) 4. To determine the risk-benefit ratio (number of subsequent interventions, complications, radiation exposure, late onset of cancer diseases, etc).

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Key information

Conditions

Coronary Artery Disease (CAD) Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute for experimental and translational cardiovascular imaging

Frankfurt am Main, Hesse, 60596, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults (=/>18 years of age)
  • Able to provide informed consent
  • Clinical indication for cardio-CT in line with the latest clinical guidelines

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Survival

    Time frame: 2 year

    number of deaths

  2. Survival

    Time frame: 5 year

    number of deaths

Sponsors and collaborators

Lead sponsor

Johann Wolfgang Goethe University Hospital

Other

Registry information

Official study title

The CArdiac Imaging RegistrY Study: Computed ToMogrAphy for Risk Stratification and Diagnostic Safety

Acronym: CARYSMA

Important dates

Study start
2017
Primary completion
2025
Study completion
2025
First posted
Jun 23, 2021
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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