Trial document




drksid header

  DRKS00000232

Trial Description

start of 1:1-Block title

Title

Regulation of microRNAs in progenitor cells of patients with coronary artery disease

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

REMIRCAD-PC

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

http://keine

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

MicroRNAs are non-coding short RNA molecules that act as regulators of gene expression. Progenitor cell therapy is a promising treatment of patients with ischemic diseases. Risk factors for coronary artery disease are known to impair progenitor cell number and function. Therefore, In patients with documented stable coronary artery disease and in healthy controls, venous blood (20 ml) will be collected once. Progenitor cells will be isolated and the expression of microRNAs will be determined in progenitor cells of patients with coronary artery disease compared to healthy controls. We will specifically focus on the influence of risk factors such as diabetes mellitus. The identified microRNAs may be novel targets for the improvement of progenitor cell function in these patients.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

MicroRNAs are non-coding short RNA molecules that act as regulators of gene expression at the post-transcriptional level. Progenitor cell therapy is a promising treatment of patients with ischemic diseases. Risk factors for coronary artery disease are known to impair progenitor cell number and function. Therefore, we aim to identify microRNAs involved in the pathology of coronary artery disease to elucidate novel targets for the improvement of progenitor cell function in these patients. We will analyze the regulation of microRNAs in specific human cell populations (e.g. CD34+ hematopoietic progenitor cells) isolated from venous blood of healthy subjects and in patients with coronary artery disease.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00000232
  •   2009/10/14
  •   [---]*
  •   yes
  •   Approved
  •   252/09, Ethikkommission des Fachbereichs Humanmedizin der Johann-Wolfgang-Goethe-Universität Frankfurt am Main
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   U1111-1111-1121 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   I25 -  Chronic ischaemic heart disease
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  • [---]*
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Detection of microRNAs in progenitor cells of patients with coronary artery disease and in healthy controls.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

[---]*

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • [---]*
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Planned
  •   2010/10/01
  •   50
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Patients with documented stable coronary artery disease. Written informed consent and willigness to give a sample of 20 ml venous blood.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

- Active infection or fever
- Pregnancy or breastfeeding
- Chronic inflammatory disease (e.g. M. Crohn, Rheumatoid Arthritis)
- HIV infection or active hepatitis
- Neoplastic disease without documented complete remission within the past 5 years
- Apoplectic insult within the past 3 months
- Impaired renal function (creatinine >2.5 mg/dl) at the time of treatment
- Relevant liver disease (GOT >2 ULN, or spontaneous INR >1.5)
- Mental retardation
- Any condition that per investigator?s judgment increases the patient?s risk or excludes adequate collection of study data
- Participation in another clinical trial within the past 30 days

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Institute for Cardiovascular Regeneration, Centre of Molecular Medicine, Goethe-University Frankfurt
    • Ms.  Prof. Dr.  Stefanie  Dimmeler 
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Institute for Cardiovascular Regeneration, Centre of Molecular Medicine, Goethe-University Frankfurt
    • Ms.  Dr.  Carmen  Urbich 
    • Theodor-Stern-Kai 7, Haus 25, 4.OG., Raum 402
    • 60590  Frankfurt
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address scientific-contact
    • Institute for Cardiovascular Regeneration, Centre of Molecular Medicine, Goethe-University Frankfurt
    • Ms.  Prof. Dr.  Stefanie  Dimmeler 
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Institute for Cardiovascular Regeneration, Centre of Molecular Medicine, Goethe-University Frankfurt
    • Ms.  Dr.  Carmen  Urbich 
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
  • start of 1:1-Block address public-contact
    • Institute for Cardiovascular Regeneration, Centre of Molecular Medicine, Goethe-University Frankfurt
    • Ms.  Prof. Dr.  Stefanie  Dimmeler 
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Deutsche Forschungsgemeinschaft DFG (Finanzierung beantragt)
    • Kennedyallee 40
    • 53170  Bonn
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting planned
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.