NCT02394262

Brief Summary

Currently, cardiac computed tomography angiography (CCTA) is a well-implemented non-invasive diagnostic imaging modality in patients with stable chest pain. Besides conventional CT-reading, CCTA is also capable to identify several morphologic and geometric characteristics of atherosclerotic plaques. Recently, the investigators showed that the use of semi-automated plaque quantification algorithm identified parameters predictive for acute coronary syndrome on top of clinical risk profiling and conventional CT-reading. In addition, several atherotrombosis biomarkers, like high-sensitivity cardiac troponins, are described as related to coronary artery disease and cardiovascular events. Prospective data with sequential analysis of atherosclerotic plaques combined with different atherothrombosis biomarkers are currently lacking, but will provide important clues about the pathophysiology of plaque progression and atherothrombosis.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable coronary-artery-disease

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2015

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 20, 2015

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

March 28, 2017

Status Verified

March 1, 2017

Enrollment Period

3.7 years

First QC Date

March 4, 2015

Last Update Submit

March 27, 2017

Conditions

Coronary Artery DiseaseAtherosclerosis

Keywords

Biological MarkersMultidetector Computed Tomography

Outcome Measures

Primary Outcomes (1)

  • Plaque progression as defined by sequential CCTA using dedicated software.

    1 year.

Study Arms (1)

Serial CCTA and atherothrombosis markers

EXPERIMENTAL

Sequential coronary CT-angiography and assesment of biomarkers involved in atherothrombosis after 1 year follow-up.

Radiation: Coronary CT-angiographyOther: Assesment of biomarkers involved in atherothrombosis

Interventions

Coronary CT-angiographyRADIATION

Sequential CCTA after one year follow-up. The first CCTA will be performed in terms of diagnostic work-up (referral outpatient Cardiology department).

Serial CCTA and atherothrombosis markers
Assesment of biomarkers involved in atherothrombosisOTHER

Sequential assesment of atherothrombis biomarkers: baseline and at 1 year follow-up.

Serial CCTA and atherothrombosis markers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a recent history of (a)typical chest pain, who underwent a coronary calcium score scan as well as CCTA.
  • Age older than 18 years and competent to perform written informed consent.
  • At least 2 coronary segments with plaques:
  • proximal lesion.
  • At least one coronary plaque consisting of a non-calcified or mixed component.

You may not qualify if:

  • Unstable angina.
  • Renal insufficiency: calculated estimated glomerular filtration rate \<45mL/min.
  • Iodine allergy.
  • Pregnancy.
  • Known history of atrial fibrillation.
  • Inconclusive baseline computed coronary CT-angiography.
  • Patients which are currently on oral vitamin K antagonists.
  • Patients which are currently using selective anticoagulants.
  • Previous PCI.
  • Previous or planned coronary artery bypass grafting.
  • Patients whereby the baseline CCTA was performed by a retrospective ECG-gated 'helical' protocol due to a high (\>90bpm) or irregular heart rate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6202, Netherlands

RECRUITING

MeSH Terms

Conditions

Coronary Artery DiseaseAtherosclerosis

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Bas Kietselaer, MD, PhD

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bas Kietselaer, MD, PhD

CONTACT

+31433871587b.kietselaer@mumc.nl

Sibel Altintas, MD

CONTACT

+31433881232s.altintas@mumc.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2015

First Posted

March 20, 2015

Study Start

March 1, 2015

Primary Completion

November 1, 2018

Study Completion

November 1, 2019

Last Updated

March 28, 2017

Record last verified: 2017-03

Locations

NL(1)