Age and Endothelial Progenitor Cell Mobilization (AGE-PCI)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
American Federation for Aging Research
Information provided by (Responsible Party):
Kreton Mavromatis, MD, FACC, Emory University
ClinicalTrials.gov Identifier:
NCT00585949
First received: December 21, 2007
Last updated: September 11, 2013
Last verified: September 2013
  Purpose

This study will help to permit the development of preventative strategies as well as cell-cased therapy for existent disease. It is hypothesized that aging is associated with reduced vascular injury-induced endothelial progenitor cell activity, resulting in impaired vascular repair and increased vascular disease. Patients with stable coronary artery disease and a control group of patients undergoing coronary angiography without angioplasty will be recruited.


Condition Intervention
Coronary Artery Disease
Procedure: Percutaneous Coronary Angioplasty

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

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Assessment of the endothelial progenitor cells colony forming units [ Time Frame: 24 hours, 1 week, and 1 month after the procedure ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 136
Study Start Date: July 2006
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Angio
Patients undergoing angiography without percutaneous coronary 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.
Other Name: PTCA, Angioplasty
Percutaneous Coronary Angioplasty
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.
Other Name: PTCA, Angioplasty

Detailed Description:

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 patients 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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Georgia
Atlanta VA Medical Center
Atlanta, Georgia, United States, 30033
Emory University Hospital
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
American Federation for Aging Research
Investigators
Principal Investigator: Kreton Mavromatis, MD Emory University
  More Information

No publications provided

Responsible Party: Kreton Mavromatis, MD, FACC, Director of Cardiac Catheterization Laboratory, Atlanta VA Medical Center, Emory University
ClinicalTrials.gov Identifier: NCT00585949     History of Changes
Other Study ID Numbers: IRB00045878
Study First Received: December 21, 2007
Last Updated: September 11, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 21, 2014