NCT03815123

Brief Summary

The aim of this Heidelberg Cardiac CT Registry (Register kardiale Computertomographie) is to assess the diagnostic and prognostic perfomance of cardiac CT exminations in a real-world patient population.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
44mo left

Started Dec 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress68%
Dec 2018Dec 2029

Study Start

First participant enrolled

December 6, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 24, 2019

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

April 27, 2020

Status Verified

April 1, 2020

Enrollment Period

10 years

First QC Date

January 21, 2019

Last Update Submit

April 23, 2020

Conditions

Evaluation of CT in Coronary Artery Stenosis

Outcome Measures

Primary Outcomes (4)

  • coronary CT angiography

    Evaluation of degree of coronary artery stenosis

    10 years

  • coronary CT angiography

    Assessment of coronary plaque composition

    10 years

  • Agreement with other imaging modalities

    Agreement with other imaging modalities

    10 years

  • Occurence of MACE

    Occurence of major adverse events

    10 years

Interventions

cardiac CTDIAGNOSTIC_TEST

The cardiac CT examinations are indicated by the referring physician. The participation in this study has no influence on the further diagnostic and therapeutic regimen.

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects referred for cardiac CT examination by their physician

You may qualify if:

  • Subjects referred for cardiac CT examination by their physician

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radiologische Praxis Heidelberg

Heidelberg, Baden-Wurttemberg, 69126, Germany

RECRUITING

Related Publications (1)

  • Andre F, Fortner P, Emami M, Seitz S, Brado M, Guckel F, Sokiranski R, Sommer A, Frey N, Gorich J, Buss SJ. Factors influencing the safety of outpatient coronary CT angiography: a clinical registry study. BMJ Open. 2022 Aug 8;12(8):e058304. doi: 10.1136/bmjopen-2021-058304.

    PMID: 35940836DERIVED

Related Links

Central Study Contacts

Johannes Goerich, Prof.

CONTACT

+491703042496jgoerich@t-online.de

Sebastian J Buss, Prof.

CONTACT

+49 6221 316930prof.buss@das-radiologische-zentrum.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med. Johannes Görich

Study Record Dates

First Submitted

January 21, 2019

First Posted

January 24, 2019

Study Start

December 6, 2018

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2029

Last Updated

April 27, 2020

Record last verified: 2020-04

Locations

DE(1)