The CArdiac Imaging RegistrY Study

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04936867

Acronym

CARYSMA

Enrollment

100

Registered

2021-06-23

Start date

2017-07-25

Completion date

2025-01-01

Last updated

2026-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease (CAD)

Brief 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. 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).

Detailed description

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Adults (=/\>18 years of age) 2. Able to provide informed consent 3. Clinical indication for cardio-CT in line with the latest clinical guidelines

Exclusion criteria

1. standard contraindications to CT (in line with local roles and guidelines - please see Appendix) 2. known allergy to iodinated contrast agent 3. suspected acute kidney injury 4. unstable hemodynamic status or arrhythmias 5. suspected acute coronary syndrome 6. manifest thyrotoxicosis

Design outcomes

Primary

Measure	Time frame	Description
Survival	2 year	number of deaths

Countries

Germany

Outcome results