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Age and Endothelial Progenitor Cell Mobilization (AGE-PCI)

This study is currently recruiting participants.
Verified by Emory University, December 2007

Sponsors and Collaborators: Emory University
American Federation for Aging Research
Information provided by: Emory University
ClinicalTrials.gov Identifier: NCT00585949
  Purpose

Coronary artery disease is a leading cause of morbidity and mortality in our society. It is initiated by the dysfunction of the lining of coronary arteries. There are several repair mechanisms that are now thought to involve circulating endothelial progenitor cells that are mobilized from the bone marrow and home to sites of endothelial injury. We hypothesize that aging is associated with reduced vascular injury induced endothelial progenitor cell activity, resulting in impaired vascular repair and increased coronary heart disease events. 96 patient with stable coronary artery disease will be enrolled in this study. They will undergo either angiography alone or angiography and angioplasty. Their venous blood will be collected immediately prior to the procedure and 20-24 hours after their procedure. The number of endothelial progenitor cells will be assessed based on their ability to form colonies and also to migrate under the influence of certain growth factors. These values will be compared between both samples. All the patients will also be contacted at 6 months, 2 and 5 years after their participation in the study and the clinical outcomes of their coronary artery disease will be correlated with the number of those aforementioned cells.


Condition Intervention
Coronary Artery Disease
Procedure: Percutaneous Coronary Angioplasty

MedlinePlus related topics:   Angioplasty    Coronary Artery Disease   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Case Control, Prospective
Official Title:   "The Effects of Age on Endothelial Progenitor Cell Mobilization in Humans"

Further study details as provided by Emory University:

Primary Outcome Measures:
  • Assessment of the endothelial progenitor cells colony forming units [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical outcomes of coronary artery disease [ Time Frame: Five years ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment:   96
Study Start Date:   July 2006
Estimated Study Completion Date:   July 2009
Estimated Primary Completion Date:   July 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts Assigned Interventions
Angio
Patients undergoing angiography without angioplasty
Procedure: Percutaneous Coronary Angioplasty
This is a procedure by which the blood vessels of the heart are imaged with an insertion of a catheter in the groin and blocked arteries are opened.
Pci
Patients undergoing angioplasty
Procedure: Percutaneous Coronary Angioplasty
This is a procedure by which the blood vessels of the heart are imaged with an insertion of a catheter in the groin and blocked arteries are opened.

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample

Study Population

Patients


Criteria

Inclusion Criteria:

  • Patients having stable coronary artery disease and undergoing either angiography or angioplasty

Exclusion Criteria:

  • Unstable coronary artery disease associated with either EKG changes or elevation of cardiac enzymes
  • Coronary intervention in the past 3 months
  • Renal insufficiency
  • Malignancy within the past 5 years except non-melanomatous skin cancers
  • Recent infection within the past 3 months requiring antibiotic treatment
  • Recent surgery requiring anesthesia within the past 3 months
  • Having inflammatory disease
  • Chemotherapy, radiation therapy or bone marrow stimulants at any time in the past
  • Menstruating women
  • Recent changes in statin, ACE-Inhs, or Angiotensin receptor blocker doses
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00585949

Contacts
Contact: Kreton Mavromatis, MD     404-329-2207     kmavro@emory.edu    
Contact: Nima Ghasemzadeh, MD     404-321-6111 ext 7917     nghase2@emory.edu    

Locations
United States, Georgia
Atlanta VA Medical Center     Recruiting
      Atlanta, Georgia, United States, 30033
      Contact: Kreton Mavromatis, MD     404-329-2207     Kmavro@emory.edu    
      Contact: Nima Ghasemzadeh, MD     404-321-6111 ext 7917     nghase2@emory.edu    
      Principal Investigator: Kreton Mavromatis, MD            
Emory University Hospital     Recruiting
      Atlanta, Georgia, United States, 30322
      Contact: Arshed A Quyyumi, MD     404-727-3655     aquyyum@emory.edu    

Sponsors and Collaborators
Emory University
American Federation for Aging Research

Investigators
Principal Investigator:     Kreton Mavromatis, MD     Emory University    
  More Information


Responsible Party:   Emory University ( Kreton Mavromatis )
Study ID Numbers:   289-2006
First Received:   December 21, 2007
Last Updated:   December 21, 2007
ClinicalTrials.gov Identifier:   NCT00585949
Health Authority:   United States: Institutional Review Board

Study placed in the following topic categories:
Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 28, 2008




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