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The Role of Stem Cells on Immune Cells in the Development of Cardiovascular Diseases (ATHEROSTEM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03172507
Recruitment Status : Completed
First Posted : June 1, 2017
Last Update Posted : April 1, 2019
Sponsor:
Collaborator:
Canisius-Wilhelmina Hospital
Information provided by (Responsible Party):
Radboud University Medical Center

Study Description
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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.

Condition or disease
Atherosclerosis Cardiovascular Diseases

Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 27 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 4 Weeks
Official Title: Phenotypic and Epigenetic "Trained Immunity" Characteristics of Hematopoietic Stem and Progenitor Cells in Patients With Established Atherosclerosis
Actual Study Start Date : September 20, 2017
Actual Primary Completion Date : August 31, 2018
Actual Study Completion Date : October 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis

Groups and Cohorts
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Group/Cohort
Atherosclerosis group
Patients with significant coronary artery disease.
Control group
Healthy controls without confirmed coronary artery disease.


Outcome Measures
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Primary Outcome Measures :
  1. Phenotypical characteristics of HSPC's [ Time Frame: Study day 2 for patients ]
    Phenotypical characteristics of HSPC's populations of patients with and without significant coronary artery disease by flowcytometry in percentages.

  2. Cytokine response of circulating monocytes [ Time Frame: Study day 2 for patients ]
    Cytokine response of monocytes of patients with and without significant coronary artery disease after 24 hour stimulation with several stimuli measured in cytokine levels.


Biospecimen Retention:   Samples With DNA
whole blood, serum, plasma and bone marrow

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03172507


Locations
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Netherlands
Department of cardiology, CWZ
Nijmegen, Gelderland, Netherlands
Department of cardiology, Radboudumc
Nijmegen, Gelderland, Netherlands
Sponsors and Collaborators
Radboud University Medical Center
Canisius-Wilhelmina Hospital
Investigators
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Principal Investigator: Niels P. Riksen, MD, PhD Radboud University Medical Center
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Radboud University Medical Center
ClinicalTrials.gov Identifier: NCT03172507    
Other Study ID Numbers: NL58806.091.16
First Posted: June 1, 2017    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Radboud University Medical Center:
Hematopoietic Stem Cells
Additional relevant MeSH terms:
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Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases