The CArdiac Imaging RegistrY Study

Coronary Artery Disease (CAD) Clinical Trial

— CARYSMA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04936867
• Other study ID #: CARYSMA Registry Study 466/16
• Status: Active, not recruiting
• Start date: July 25, 2017
• Est. completion date: December 1, 2030

Study information

• Verified date: July 2023
• Source: Johann Wolfgang Goethe University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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).

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Disease (CAD)

Locations

Country	Name	City	State
Germany	Institute for experimental and translational cardiovascular imaging	Frankfurt Am Main	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospital

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival	number of deaths	2 year
Primary	Survival	number of deaths	5 year