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The CArdiac Imaging RegistrY Study (CARYSMA)

J

Johann Wolfgang Goethe University Hospital

Status

Completed

Conditions

Coronary Artery Disease (CAD)

Study type

Observational

Funder types

Other

Identifiers

NCT04936867
CARYSMA Registry Study 466/16

Details and patient eligibility

About

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).

Full 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).

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial contacts and locations

1

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Central trial contact

Valentina O Puentmann, MD, PhD; Franziska Weis

Data sourced from clinicaltrials.gov

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