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

NCT ID: NCT03172507

Last Updated: 2019-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

27 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-20

Study Completion Date

2018-10-01

Brief Summary

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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

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Conditions

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Atherosclerosis Cardiovascular Diseases

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Atherosclerosis group

Patients with significant coronary artery disease.

No interventions assigned to this group

Control group

Healthy controls without confirmed coronary artery disease.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Canisius-Wilhelmina Hospital

OTHER

Sponsor Role collaborator

Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Niels P. Riksen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

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Department of cardiology, CWZ

Nijmegen, Gelderland, Netherlands

Site Status

Department of cardiology, Radboudumc

Nijmegen, Gelderland, Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 33168134 (View on PubMed)

Other Identifiers

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NL58806.091.16

Identifier Type: -

Identifier Source: org_study_id

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