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

Phenotypic and Epigenetic Trained Immunity Characteristics of Hematopoietic Stem and Progenitor Cells in Patients With Established Atherosclerosis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03172507

Acronym

ATHEROSTEM

Enrollment

Registered

2017-06-01

Start date

2017-09-20

Completion date

2018-10-01

Last updated

2019-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis, Cardiovascular Diseases

Keywords

Hematopoietic Stem Cells

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

18 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Phenotypical characteristics of HSPC's	Study day 2 for patients	Phenotypical characteristics of HSPC's populations of patients with and without significant coronary artery disease by flowcytometry in percentages.
Cytokine response of circulating monocytes	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.

Countries

Netherlands

Outcome results