NCT02904239

Brief Summary

Modern high-end CT scanners with faster scan acquisition times now allow for routine assessment of cardiac pathologies, which could result in numerous incidental cardiac findings on standard thoracic CT angiography (CTA) scans. The CaPaCT-study aims to assesses the presence, management and possible clinical impact of incidental cardiac pathologies which are becoming visible on standard thoracic CT scans performed on new high-end scanners.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
221

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2016

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 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2018

Completed
Last Updated

May 2, 2018

Status Verified

September 1, 2017

Enrollment Period

1.7 years

First QC Date

September 13, 2016

Last Update Submit

April 30, 2018

Conditions

Coronary Artery Disease

Keywords

Multidetector Computed TomographyIncidental cardiac findingsThoracic high-pitch Computed TomographyManagement guidelines

Outcome Measures

Primary Outcomes (1)

  • Evaluate visibility and management of coronary artery disease (CAD)

    Evaluating visibility and management of CAD on standard thoracic CT with help of the CAD-RAD system.

    One year

Secondary Outcomes (2)

  • Objective image quality

    One year

  • Subjective image quality

    One year

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All consecutive patients referred for thoracic CT-scanning.

You may qualify if:

  • \- Standard non-ECG triggered thoracic CT scanning.

You may not qualify if:

  • Iodine allergy
  • Renal insufficiency (GFR \< 30mL/min)
  • Pregnancy
  • Age \< 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6202AZ, Netherlands

Location

Related Publications (3)

  • Khakoo AY, Yeh ET. Therapy insight: Management of cardiovascular disease in patients with cancer and cardiac complications of cancer therapy. Nat Clin Pract Oncol. 2008 Nov;5(11):655-67. doi: 10.1038/ncponc1225. Epub 2008 Sep 16.

    PMID: 18797437BACKGROUND

  • Kannel WB, McGee DL. Diabetes and cardiovascular disease. The Framingham study. JAMA. 1979 May 11;241(19):2035-8. doi: 10.1001/jama.241.19.2035.

    PMID: 430798BACKGROUND

  • Aktas MK, Ozduran V, Pothier CE, Lang R, Lauer MS. Global risk scores and exercise testing for predicting all-cause mortality in a preventive medicine program. JAMA. 2004 Sep 22;292(12):1462-8. doi: 10.1001/jama.292.12.1462.

    PMID: 15383517BACKGROUND

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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2016

First Posted

September 16, 2016

Study Start

July 1, 2016

Primary Completion

March 5, 2018

Study Completion

March 5, 2018

Last Updated

May 2, 2018

Record last verified: 2017-09

Locations

NL(1)