NCT02272530

Brief Summary

The aim of this study is to investigate wether change in endothelial nitric oxid synthase of blood cells (erythrocytes and peripheral blood mononuclear cells (PBMC)) has an influence on development and progression of cardiovascular diseases.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2012

Longer than P75 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

July 1, 2012

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

October 21, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 23, 2014

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

February 16, 2021

Status Verified

February 1, 2021

Enrollment Period

8.5 years

First QC Date

October 21, 2014

Last Update Submit

February 15, 2021

Conditions

Red Blood CellPeripheral Blood Mononuclear CellEndothelial NO-synthase

Keywords

Endothelial NO-synthasered blood cellerythrocytesPeripheral Blood Mononuclear Cellcardiovascular disease

Outcome Measures

Primary Outcomes (1)

  • Blood examination

    Following parameters will be examined: * Blood count (red cells, white cells, platelets, hemoglobin, hematocrit, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC), red blood cell distribution width (RDW), mean platelet volume (MPV) ) * Creatinin * Urea * Glucose * Glycated hemoglobin (HbA1c) * Cholesterol * Triglyceride * C-reactive Protein * Apolipoprotein

    baseline

Secondary Outcomes (6)

  • Protein expression

    baseline

  • Asymmetric dimethylarginine (ADMA) and Cytokine

    baseline

  • Microparticles

    baseline

  • Immunocytochemistry

    baseline

  • Nitric oxid metabolite and proteins in blood plasma, red blood cells and peripheral blood mononuclear cells (PBMN)

    baseline

  • +1 more secondary outcomes

Study Arms (2)

Healthy

100 healthy volunteers in age of 20-75 years

Patients

100 patients with stable coronary artery disease and accordingly endothelial dysfunction

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

100 healthy volunteers and 100 patient with stable coronary artery disease

You may qualify if:

  • healthy volunteers
  • Patients: stable coronary artery disease with accordingly endothelial dysfunction

You may not qualify if:

  • acute inflammation (CRP\>0,5 mg/dl, leucocyte \>11000/dl)
  • malignant diseases
  • acute or terminated kidney disease
  • relevant heart failure (NYHA III-IV)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Duesseldorf

Düsseldorf, 40225, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Malte Kelm, Prof. MD

    Department of Cardiology, Pneumology and Angiology, University Hospital Duesseldorf

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator Prof. Dr. Malte Kelm

Study Record Dates

First Submitted

October 21, 2014

First Posted

October 23, 2014

Study Start

July 1, 2012

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

February 16, 2021

Record last verified: 2021-02

Locations

DE(1)