NCT04936867

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 25, 2017

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

June 16, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 23, 2021

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

January 6, 2026

Status Verified

January 1, 2026

Enrollment Period

7.4 years

First QC Date

June 16, 2021

Last Update Submit

January 2, 2026

Conditions

Coronary Artery Disease (CAD)

Outcome Measures

Primary Outcomes (2)

  • Survival

    number of deaths

    2 year

  • Survival

    number of deaths

    5 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults referred to clinical cardiac computertomography imaging

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for experimental and translational cardiovascular imaging

Frankfurt am Main, Hesse, 60596, Germany

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical professor

Study Record Dates

First Submitted

June 16, 2021

First Posted

June 23, 2021

Study Start

July 25, 2017

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

January 6, 2026

Record last verified: 2026-01

Locations

DE(1)