Coronary Heart DiseasePHAMOSNCT01442948
CD16+ Monocytes in Coronary Heart Disease (CHD)
An observational study of Coronary Heart Disease, run by Martin-Luther-Universität Halle-Wittenberg at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- May 2007to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- angiographically proven coronary heart disease
- Age > 18 years
Who cannot join
- life expectancy < 12 months
- inability to participate in the trial (to give written informed consent)
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Clinic of the Martin Luther-University Halle-Wittenberg
Halle, Please Select, 06120
About this study
Official title: 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.
- Conditions
- Coronary Heart Disease
- Keywords
- -CD16+ monocytes
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Acute coronary syndrome | Not described | |
| Stable Angina | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
- non-fatal myocardial infarction
- cardiovascular death
- stroke
- total death
Measured: 12 months
Subgroup analysis for absolute numbers of CD16+ monocytes stratified by tertiles in relation to the combined endpoint
Subgroups of patients:
Patients with stable Angina Patients with acute coronary syndrome
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2011 (estimated)
- Study startMay 2007
- Primary completionAug 2009
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Martin-Luther-Universität Halle-Wittenberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Axel Schlitt, Martin-Luther-Universität Halle-Wittenberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01442948
- Sponsor's protocol ID
- CD16PHAMOS
- Acronym
- PHAMOS
- Status last verified
- Sep 2011
- First submitted
- 22 Sep 2011
- Last updated
- 29 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CD16+ Monocytes in Patients With Coronary Heart Disease
- ClinicalTrials.gov ID
- NCT01442948
- Acronym / sponsor ID
- PHAMOS / CD16PHAMOS
- Conditions
- Coronary Heart Disease
- Keywords
- -CD16+ monocytes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Martin-Luther-Universität Halle-WittenbergUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 29 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute coronary syndrome | – | – |
| Stable Angina | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- angiographically proven coronary heart disease
- Age > 18 years
Key exclusion criteria (2 listed)
- life expectancy < 12 months
- inability to participate in the trial (to give written informed consent)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
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
Subgroup analysis for absolute numbers of CD16+ monocytes stratified by tertiles in relation to the combined endpoint
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2011.
Related trials for Coronary Heart Disease
RecruitingPhase 2/3
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Heart Failure, Left Ventricular Systolic Dysfunction
RecruitingPhase 4
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ST Elevation Myocardial Infarction
Active, not recruitingPhase 4
Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD
Coronary Artery Disease
Active, not recruiting
VOLT CE Mark Study
Atrial Arrhythmia, Atrial Fibrillation
Recruiting
SYMmetric Valve fraME Expansion To Reduce hYpoattenuated Leaflet Thickening After Balloon-expandable TAVI: the SYMMETRY Trial
Aortic Valve Stenosis and/or Insufficiency, Hypoattenuated Leaflet Thickening
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Heart Disease, run by Martin-Luther-Universität Halle-Wittenberg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute numbers of CD16+ monocytes stratified by tertiles related to the incidence of the combined endpoint (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2011.