Epigenetic Reprogramming of Monocytes in Patients With Coronary Atherosclerosis

April 21, 2016 updated by: Radboud University Medical Center
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.

Study Overview

Status

Completed

Conditions

Detailed Description

Rationale: The innate immune system plays a pivotal role in the development and progression of atherosclerosis. Recently, it was reported that monocytes can develop a long-lasting immunological memory after stimulation with various microorganisms, which has been termed 'trained innate immunity'. This memory is induced by epigenetic reprogramming. We hypothesize that trained monocytes augment atherogenesis.

Objective: The main objective is to study whether patients with coronary atherosclerosis show specific epigenetic changes in the promoter regions of pro-inflammatory cytokines and chemokines and whether this correlates with the inflammatory phenotype of these cells.

Study design: Observational study

Study population: Adult patients who have had computed tomography coronary angiography because of chest pain: 20 patients without atherosclerosis and 20 patients with severe atherosclerosis will be included.

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Nijmegen, Netherlands, 6500 GA
        • Radboud University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
patients
patients with documented atherosclerosis on a CCTA
controls
patients without atherosclerosis on a CCTA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Epigenetic modifications in circulating monocytes
Time Frame: baseline
baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Inflammatory phenotype
Time Frame: baseline
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

Canisius-Wilhelmina Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

March 13, 2015

First Submitted That Met QC Criteria

March 18, 2015

First Posted (Estimate)

March 19, 2015

Study Record Updates

Last Update Posted (Estimate)

April 22, 2016

Last Update Submitted That Met QC Criteria

April 21, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SB EpiCard

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Atherosclerosis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe