NCT01442948

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 29, 2011

Completed
Last Updated

September 29, 2011

Status Verified

September 1, 2011

Enrollment Period

2.3 years

First QC Date

September 22, 2011

Last Update Submit

September 28, 2011

Conditions

Coronary Heart Disease

Keywords

-CD16+ monocytes

Outcome Measures

Primary Outcomes (1)

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

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

    12 months

Secondary Outcomes (2)

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

    12 months

  • Subgroup analysis for absolute numbers of CD16+ monocytes stratified by tertiles in relation to the combined endpoint

    12 months

Study Arms (2)

Acute coronary syndrome

Stable Angina

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • angiographically proven coronary heart disease
  • Age \> 18 years

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Clinic of the Martin Luther-University Halle-Wittenberg

Halle, Please Select, 06120, Germany

Location

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Physician

Study Record Dates

First Submitted

September 22, 2011

First Posted

September 29, 2011

Study Start

May 1, 2007

Primary Completion

August 1, 2009

Study Completion

December 1, 2010

Last Updated

September 29, 2011

Record last verified: 2011-09

Locations

DE(1)