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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03172507
Recruitment Status : Completed
First Posted : June 1, 2017
Last Update Posted : April 1, 2019
Sponsor:
Collaborator:
Canisius-Wilhelmina Hospital
Information provided by (Responsible Party):
Radboud University Medical Center

Tracking Information
First Submitted Date March 31, 2017
First Posted Date June 1, 2017
Last Update Posted Date April 1, 2019
Actual Study Start Date September 20, 2017
Actual Primary Completion Date August 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 29, 2017)
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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 Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration 4 Weeks
Biospecimen Retention:   Samples With DNA
Description:
whole blood, serum, plasma and bone marrow
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.
Condition
  • Atherosclerosis
  • Cardiovascular Diseases
Intervention Not Provided
Study Groups/Cohorts
  • Atherosclerosis group
    Patients with significant coronary artery disease.
  • Control group
    Healthy controls without confirmed coronary artery disease.
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 29, 2019)
27
Original Estimated Enrollment
 (submitted: May 29, 2017)
30
Actual Study Completion Date October 1, 2018
Actual Primary Completion Date August 31, 2018   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT03172507
Other Study ID Numbers NL58806.091.16
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Radboud University Medical Center
Original Responsible Party Same as current
Current Study Sponsor Radboud University Medical Center
Original Study Sponsor Same as current
Collaborators Canisius-Wilhelmina Hospital
Investigators
Principal Investigator: Niels P. Riksen, MD, PhD Radboud University Medical Center
PRS Account Radboud University Medical Center
Verification Date October 2018