The CArdiac Imaging RegistrY Study (CARYSMA)

July 12, 2023 updated by: Valentina Puentmann, Johann Wolfgang Goethe University Hospital

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

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).

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Valentina O Puentmann, MD, PhD
  • Phone Number: 004969630184491
  • Email: cvi-research@kgu.de

Study Contact Backup

Study Locations

  • Germany
    • Hessen
      • Frankfurt Am Main, Hessen, Germany, 60596
        • Institute for experimental and translational cardiovascular imaging

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults referred to clinical cardiac computertomography imaging

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: 2 year
number of deaths
2 year
Survival
Time Frame: 5 year
number of deaths
5 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johann Wolfgang Goethe University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 25, 2017

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

June 16, 2021

First Submitted That Met QC Criteria

June 16, 2021

First Posted (Actual)

June 23, 2021

Study Record Updates

Last Update Posted (Actual)

July 13, 2023

Last Update Submitted That Met QC Criteria

July 12, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CARYSMA Registry Study 466/16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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