Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:39 PM
Study NCT ID:
NCT04936867
Status:
COMPLETED
Last Update Posted:
2025-04-03
First Post:
2021-06-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The CArdiac Imaging RegistrY Study
Sponsor:
Johann Wolfgang Goethe University Hospital
Organization:
Study Overview
Official Title:
The CArdiac Imaging RegistrY Study: Computed ToMogrAphy for Risk Stratification and Diagnostic Safety
Status:
COMPLETED
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CARYSMA
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).
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).
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).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: