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

September 28, 2011 updated by: Axel Schlitt, Martin-Luther-Universität Halle-Wittenberg

CD16+ Monocytes in Patients With Coronary Heart Disease

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Please Select
      • Halle (Saale), Please Select, Germany, 06120
        • University Clinic of the Martin Luther-University Halle-Wittenberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Acute coronary syndrome
Stable Angina

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Martin-Luther-Universität Halle-Wittenberg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

September 22, 2011

First Submitted That Met QC Criteria

September 28, 2011

First Posted (Estimate)

September 29, 2011

Study Record Updates

Last Update Posted (Estimate)

September 29, 2011

Last Update Submitted That Met QC Criteria

September 28, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CD16PHAMOS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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