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Completed

NCT Number: NCT03172507

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

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.

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Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

Male

Study type

Observational

Primary location

Department of cardiology, CWZ, Nijmegen, Gelderland, Netherlands

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Canisius-Wilhelmina Hospital

Registry information

Official study title

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

Acronym: ATHEROSTEM

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 1, 2017
Registry last updated
Apr 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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