CARYSMA: The CArdiac Imaging RegistrY Study

Sponsor

Johann Wolfgang Goethe University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04936867

Collaborator

(none)

5,000

Enrollment

Location

160.2

Anticipated Duration (Months)

31.2

Patients Per Site Per Month

Study Details

Study Description

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:

To determine the prevalence of CAD for age, gender, ethnicity relative to established risk models
To determine associations between CAD severity and plaque type and:
with traditional risk factors (arterial hypertension, diabetes, hypercholesterolemia, smoking)
blood markers of increased cardiovascular risk
To determine predictive associations of between CAD with outcome (endpoint definitions in appendix)
To determine the risk-benefit ratio (number of subsequent interventions, complications, radiation exposure, late onset of cancer diseases, etc).

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease (CAD)

Detailed Description

Particular aims include:

To determine the prevalence of CAD for age, gender, ethnicity relative to established risk models
To determine associations between CAD severity and plaque type and:
with traditional risk factors (arterial hypertension, diabetes, hypercholesterolemia, smoking)
blood markers of increased cardiovascular risk
To determine predictive associations of between CAD with outcome (endpoint definitions in appendix)
To determine the risk-benefit ratio (number of subsequent interventions, complications, radiation exposure, late onset of cancer diseases, etc).

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

5000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jul 25, 2017

Anticipated Primary Completion Date :

Jan 1, 2025

Anticipated Study Completion Date :

Dec 1, 2030

Outcome Measures

Primary Outcome Measures

Survival [2 year]
number of deaths
Survival [5 year]
number of deaths

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adults (=/>18 years of age)
Able to provide informed consent
Clinical indication for cardio-CT in line with the latest clinical guidelines

Exclusion Criteria:

standard contraindications to CT (in line with local roles and guidelines - please see Appendix)
known allergy to iodinated contrast agent
suspected acute kidney injury
unstable hemodynamic status or arrhythmias
suspected acute coronary syndrome
manifest thyrotoxicosis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institute for experimental and translational cardiovascular imaging	Frankfurt Am Main	Hessen	Germany	60596

Sponsors and Collaborators

Johann Wolfgang Goethe University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Valentina Puentmann, Clinical professor, Johann Wolfgang Goethe University Hospital

ClinicalTrials.gov Identifier:

NCT04936867

Other Study ID Numbers:

CARYSMA Registry Study 466/16

First Posted:

Jun 23, 2021

Last Update Posted:

Jun 23, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Coronary Artery Disease

Study Results

No Results Posted as of Jun 23, 2021