NCT04827316

Brief Summary

In this study the investigators retrospectively and prospectively collect information from enrolled subjects undergoing CCTA and evaluate the association of cardiac and non-cardiac imaging with laboratory markers and clinical data including outcome.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
4,200

participants targeted

Target at P75+ for all trials

Timeline
56mo left

Started Jun 2017

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 Progress66%
Jun 2017Feb 2031

Study Start

First participant enrolled

June 1, 2017

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

March 29, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2031

Last Updated

October 18, 2024

Status Verified

October 1, 2024

Enrollment Period

13.7 years

First QC Date

March 29, 2021

Last Update Submit

October 16, 2024

Conditions

Coronary Artery DiseaseCoronary ArteriosclerosisCoronary; Ischemic

Keywords

Cardiovascular Computed Tomography

Outcome Measures

Primary Outcomes (1)

  • All-cause death.

    The primary endpoint is the time to first occurrence of death from all-causes.

    10 years

Secondary Outcomes (2)

  • Major adverse cardiovascular events (MACE)

    10 years

  • Other outcome

    10 years

Study Arms (1)

Patients undergoing clinically indicated CCTA

Patients undergoing clinically indicated CCTA

Eligibility Criteria

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

The registry foreseen a prospective cohort composed by patients undergoing clinically indicated CCTA and by a retrospective population of patients that have undergone CCTA 1st June 2017 to 31st December 2020. The principal investigator confirms that no patient's personal health data will be collected if a written or documented oral refusal exist.

You may qualify if:

  • Adult individual \>18 years
  • Undergoing clinically indicated CCTA
  • Signed informed consent or waiver

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology, University Hospital Bern, Inselspital, Bern

Bern, 3010, Switzerland

RECRUITING

MeSH Terms

Conditions

Coronary Artery DiseaseIschemia

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Christoph Gräni, MD, PhD

    Department of Cardiology, University Hospital Bern,

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christoph Gräni, MD, PHD

CONTACT

+41 31 632 4508christoph.graeni@insel.ch

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2021

First Posted

April 1, 2021

Study Start

June 1, 2017

Primary Completion (Estimated)

February 1, 2031

Study Completion (Estimated)

February 1, 2031

Last Updated

October 18, 2024

Record last verified: 2024-10

Locations

CH(1)