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OpenTrials
Completed

NCT Number: NCT01442948

CD16+ Monocytes in Coronary Heart Disease (CHD)

Monocytes may be separated into phenotypically and functionally distinct cell types by the presence or absence of the lipopolysaccharide receptor CD14 and the Fcγ-receptor CD16. The investigators hypothesize that the total numbers of CD16+ monocytes are significantly related to cardiovascular outcome in patients with angiographically proven coronary heart disease.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Clinic of the Martin Luther-University Halle-Wittenberg

Halle, Please Select, 06120, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • angiographically proven coronary heart disease
  • Age > 18 years

Exclusion criteria

  • life expectancy < 12 months
  • inability to participate in the trial (to give written informed consent)

Treatment and study plan

Primary outcomes

  1. Absolute numbers of CD16+ monocytes stratified by tertiles related to the incidence of the combined endpoint

    Time frame: 12 months

    Incidence of the combined endpoint (non-fatal myocardial infarction, cardiovascular death, stroke) during a follow-up of 12 months

Secondary outcomes

  1. Absolute numbers of CD16+ monocytes stratified by tertiles related to the incidence of each part of the combined endpoint + total death

    Time frame: 12 months

    • non-fatal myocardial infarction
    • cardiovascular death
    • stroke
    • total death
  2. Subgroup analysis for absolute numbers of CD16+ monocytes stratified by tertiles in relation to the combined endpoint

    Time frame: 12 months

    Subgroups of patients:

    Patients with stable Angina Patients with acute coronary syndrome

Sponsors and collaborators

Lead sponsor

Martin-Luther-Universität Halle-Wittenberg

Other

Registry information

Official study title

CD16+ Monocytes in Patients With Coronary Heart Disease

Acronym: PHAMOS

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Sep 29, 2011
Registry last updated
Sep 29, 2011

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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