NCT03172507

Brief Summary

An observational pilot proof-of-principle study. 15 patients with significant coronary artery disease and 15 matched controls. To investigate whether long-term activation of the innate immune system, named 'trained innate immunity', occurs at the level of the bone marrow progenitor cells in patients with significant coronary artery disease and whether this correlates with the proinflammatory phenotype of monocytes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

March 31, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 1, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

September 20, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

April 1, 2019

Status Verified

October 1, 2018

Enrollment Period

12 months

First QC Date

March 31, 2017

Last Update Submit

March 29, 2019

Conditions

AtherosclerosisCardiovascular Diseases

Keywords

Hematopoietic Stem Cells

Outcome Measures

Primary Outcomes (2)

  • Phenotypical characteristics of HSPC's

    Phenotypical characteristics of HSPC's populations of patients with and without significant coronary artery disease by flowcytometry in percentages.

    Study day 2 for patients

  • Cytokine response of circulating monocytes

    Cytokine response of monocytes of patients with and without significant coronary artery disease after 24 hour stimulation with several stimuli measured in cytokine levels.

    Study day 2 for patients

Study Arms (2)

Atherosclerosis group

Patients with significant coronary artery disease.

Control group

Healthy controls without confirmed coronary artery disease.

Eligibility Criteria

Age18 Years - 75 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study will include 15 patients with significant coronary artery disease and 15 patients without significant coronary artery disease. Patients who have been presented to the cardiology departments of the CWZ hospital or Radboud University Medical Centre and have undergone CCTA in the past two years are eligible to participate if they meet the in- and exclusion criteria.

You may qualify if:

  • Age ≥18 and ≤75 years
  • With or without significant coronary artery disease on CCTA
  • Written informed consent

You may not qualify if:

  • Chronic infections
  • Diabetes mellitus
  • Medical history of any disease associated with immune deficiency
  • Clinically significant infections within 3 months prior to study entry
  • Recent hospital admission or surgery with general anaesthesia
  • Known chronic kidney or liver disease
  • Previous vaccination within 3 months prior to study entry
  • Inability to personally provide written informed consent
  • Inability to undergo PET-CT scanning
  • Chronic use of anti-inflammatory drugs such as NSAIDs
  • History of haematological malignant disease
  • Documented bleeding diathesis or thrombocytopenia
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of cardiology, CWZ

Nijmegen, Gelderland, Netherlands

Location

Department of cardiology, Radboudumc

Nijmegen, Gelderland, Netherlands

Location

Related Publications (1)

  • Noz MP, Bekkering S, Groh L, Nielen TM, Lamfers EJ, Schlitzer A, El Messaoudi S, van Royen N, Huys EH, Preijers FW, Smeets EM, Aarntzen EH, Zhang B, Li Y, Bremmers ME, van der Velden WJ, Dolstra H, Joosten LA, Gomes ME, Netea MG, Riksen NP. Reprogramming of bone marrow myeloid progenitor cells in patients with severe coronary artery disease. Elife. 2020 Nov 10;9:e60939. doi: 10.7554/eLife.60939.

    PMID: 33168134DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, plasma and bone marrow

MeSH Terms

Conditions

AtherosclerosisCardiovascular Diseases

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Niels P. Riksen, MD, PhD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
4 Weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2017

First Posted

June 1, 2017

Study Start

September 20, 2017

Primary Completion

August 31, 2018

Study Completion

October 1, 2018

Last Updated

April 1, 2019

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

NL(2)