NCT00585949

Brief Summary

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 will be enrolled in this observational study and will undergo either angiography alone or angiography and angioplasty. Participants will be followed for 5 years.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
123

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2006

Typical duration for all trials

Geographic Reach
1 country

2 active sites

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, 2006

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 4, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 9, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 9, 2008

Completed
Last Updated

March 5, 2020

Status Verified

March 1, 2020

Enrollment Period

2.3 years

First QC Date

December 21, 2007

Last Update Submit

March 2, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in endothelial progenitor cells colony forming units

    Activity of endothelial progenitor cells will be assessed in participants following their procedures.

    24 hours, 1 week, and 1 month after the procedure

Secondary Outcomes (1)

  • Change in clinical outcomes of coronary artery disease

    Up to 5 years

Study Arms (2)

Angiography

Patients undergoing coronary angiography without percutaneous coronary angioplasty

Procedure: Angiography

Percutaneous Coronary Angioplasty

Patients with stable coronary artery disease undergoing angioplasty

Procedure: Percutaneous Coronary Angioplasty

Interventions

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.

Percutaneous Coronary Angioplasty
AngiographyPROCEDURE

Angiography is an imaging technique to see coronary blood vessels.

Angiography

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with stable coronary artery disease

You may qualify if:

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

You may not qualify if:

  • 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, angiotensin-converting enzyme (ACE) inhibitors, or angiotensin receptor blocker doses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Atlanta VA Medical Center

Atlanta, Georgia, 30033, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Angioplasty, Balloon, CoronaryCerebral Angiography

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Angioplasty, BalloonAngioplastyCatheterizationTherapeuticsMyocardial RevascularizationCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeEndovascular ProceduresVascular Surgical ProceduresPercutaneous Coronary InterventionMinimally Invasive Surgical ProceduresThoracic Surgical ProceduresInvestigative TechniquesNeuroradiographyNeuroimagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisAngiographyRadiographyDiagnostic Techniques, CardiovascularDiagnostic Techniques, Neurological

Study Officials

  • Kreton Mavromatis, MD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 21, 2007

First Posted

January 4, 2008

Study Start

July 1, 2006

Primary Completion

October 9, 2008

Study Completion

October 9, 2008

Last Updated

March 5, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations