NCT02393768

Brief Summary

In this study, the investigators will determine whether patients with documented atherosclerosis are characterized by specific epigenetic changes in circulating cells of the innate immune system, compared to patients without atherosclerosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2014

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

October 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 19, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

April 22, 2016

Status Verified

April 1, 2016

Enrollment Period

1 year

First QC Date

March 13, 2015

Last Update Submit

April 21, 2016

Conditions

Atherosclerosis

Outcome Measures

Primary Outcomes (1)

  • Epigenetic modifications in circulating monocytes

    baseline

Secondary Outcomes (1)

  • Inflammatory phenotype

    baseline

Study Arms (2)

patients

patients with documented atherosclerosis on a CCTA

controls

patients without atherosclerosis on a CCTA

Eligibility Criteria

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

Adult patients \>18 years who have underwent CCTa scanning beacuse of chest pain.

You may qualify if:

  • Patients (male/female),
  • aged \>18 years,
  • admitted to the acute coronary unit of the CWZ hospital for evaluation of chest pain.
  • No coronary atherosclerosis
  • Or Severe atherosclerosis

You may not qualify if:

  • Signs or symptoms of a current infection (fever, chills)
  • Auto-immune diseases (such as rheumatoid arthritis)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud university medical center

Nijmegen, 6500 GA, Netherlands

Location

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2015

First Posted

March 19, 2015

Study Start

October 1, 2014

Primary Completion

October 1, 2015

Study Completion

December 1, 2015

Last Updated

April 22, 2016

Record last verified: 2016-04

Locations

NL(1)