The CArdiac Imaging RegistrY Study

Completed

• Conditions: Coronary Artery Disease (CAD)

• Registration Number: NCT04936867
• Lead Sponsor: Johann Wolfgang Goethe University Hospital

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).

Study Timeline

• Study Start: 2017-07-25
• Study First Submitted: 2021-06-16
• Study First Submitted QC: 2021-06-16
• Study First Posted: 2021-06-23
• Primary Completion: 2025-01-01
• Study Completion: 2025-01-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival	5 year	number of deaths

Trial Locations

Locations (1)

Institute for experimental and translational cardiovascular imaging; 🇩🇪 Frankfurt Am Main, Hessen, Germany