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

Completed

• Conditions: Atherosclerosis; Cardiovascular Diseases

• Registration Number: NCT03172507
• Lead Sponsor: Radboud University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-31
• Study First Submitted QC: 2017-05-29
• Study First Posted: 2017-06-01
• Study Start: 2017-09-20
• Primary Completion: 2018-08-31
• Status Verified: 2018-10
• Study Completion: 2018-10-01
• Last Update Submitted: 2019-03-29
• Last Update Posted: 2019-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 27

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Department of cardiology, CWZ; 🇳🇱 Nijmegen, Gelderland, Netherlands

Department of cardiology, Radboudumc; 🇳🇱 Nijmegen, Gelderland, Netherlands