Coronary Artery Disease (CAD) Clinical Trial
— CARYSMAOfficial title:
The CArdiac Imaging RegistrY Study: Computed ToMogrAphy for Risk Stratification and Diagnostic Safety
Verified date | July 2023 |
Source | Johann Wolfgang Goethe University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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).
Status | Active, not recruiting |
Enrollment | 5000 |
Est. completion date | December 1, 2030 |
Est. primary completion date | January 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Institute for experimental and translational cardiovascular imaging | Frankfurt Am Main | Hessen |
Lead Sponsor | Collaborator |
---|---|
Johann Wolfgang Goethe University Hospital |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Survival | number of deaths | 2 year | |
Primary | Survival | number of deaths | 5 year |
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