Clinical trial NCT03172507: The Role of Stem Cells on Immune Cells in the Development of Cardiovascular Diseases
Official title: Phenotypic and Epigenetic "Trained Immunity" Characteristics of Hematopoietic Stem and Progenitor Cells in Patients With Established Atherosclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerosis
Cardiovascular Diseases
Keywords: Hematopoietic Stem Cells
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Canisius-Wilhelmina Hospital
First posted: 2017-06-01
Enrollment: 27
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Phenotypical characteristics of HSPC's
timeFrame: Study day 2 for patients
measure: Cytokine response of circulating monocytes
timeFrame: Study day 2 for patients
Secondary outcomes:
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Department of cardiology, CWZ
state: Gelderland
city: Nijmegen
country: Netherlands
facility: Department of cardiology, Radboudumc
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: Niels P. Riksen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.