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

Cardiovascular Diseases Clinical Trial

— ATHEROSTEM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03172507
• Other study ID #: NL58806.091.16
• Status: Completed
• Start date: September 20, 2017
• Est. completion date: October 1, 2018

Study information

• Verified date: October 2018
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: October 1, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Cardiovascular Diseases

Locations

Country	Name	City	State
Netherlands	Department of cardiology, CWZ	Nijmegen	Gelderland
Netherlands	Department of cardiology, Radboudumc	Nijmegen	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University	Canisius-Wilhelmina Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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