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CD16+ Monocytes in Coronary Heart Disease (CHD) (PHAMOS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Axel Schlitt, Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier:
NCT01442948
First received: September 22, 2011
Last updated: September 28, 2011
Last verified: September 2011
History of Changes
  Purpose

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.


Condition
Coronary Heart Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: CD16+ Monocytes in Patients With Coronary Heart Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Martin-Luther-Universität Halle-Wittenberg:

Primary Outcome Measures:
  • Absolute numbers of CD16+ monocytes stratified by tertiles related to the incidence of the combined endpoint [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Incidence of the combined endpoint (non-fatal myocardial infarction, cardiovascular death, stroke) during a follow-up of 12 months


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    • non-fatal myocardial infarction
    • cardiovascular death
    • stroke
    • total death

  • Subgroup analysis for absolute numbers of CD16+ monocytes stratified by tertiles in relation to the combined endpoint [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    Subgroups of patients:

    Patients with stable Angina Patients with acute coronary syndrome



Enrollment: 1000
Study Start Date: May 2007
Study Completion Date: December 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Acute coronary syndrome
Stable Angina

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with angiographically proven coronary heart disease, admitted to the Department of Medicine or Department of Cardiothoracic Surgery of the Martin Luther-University Halle-Wittenberg

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01442948

Locations
Germany
University Clinic of the Martin Luther-University Halle-Wittenberg
Halle (Saale), Please Select, Germany, 06120
Sponsors and Collaborators
Martin-Luther-Universität Halle-Wittenberg
  More Information

No publications provided

Responsible Party: Axel Schlitt, Senior Physician, Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier: NCT01442948     History of Changes
Other Study ID Numbers: CD16PHAMOS
Study First Received: September 22, 2011
Last Updated: September 28, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Martin-Luther-Universität Halle-Wittenberg:
-CD16+ monocytes

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013