- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00585949
Age and Endothelial Progenitor Cell Mobilization (AGE-PCI)
The Effects of Age on Endothelial Progenitor Cell Mobilization in Humans
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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. Such endothelial dysfunction permits vascular wall inflammation, smooth muscle cell proliferation, and thrombosis, which progresses to coronary artery stenosis and occlusion, and manifests as myocardial ischemia and infarction. Endothelial injury can be due to the damaging effects of various cardiovascular risk factors and it can also be induced by balloon injury associated with coronary angioplasty. Damaged endothelium can be repaired via endogenous mechanisms, such as by the migration and proliferation of neighboring uninjured mature endothelial cells, or by the mobilization and homing of bone-marrow-derived circulating endothelial progenitor cells (EPCs).
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. The researchers of this study 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. Patients with stable coronary artery disease will be enrolled in this study. They will undergo either angiography alone or angiography and angioplasty. Venous blood will be collected immediately prior to the procedure and 20-24 hours after the 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. Study participants will also be contacted at 6 months, and 2 and 5 years after their participation in the study. The clinical outcomes of the participant's coronary artery disease will be correlated with the number of endothelial progenitor cells.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
-
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Georgia
-
Atlanta, Georgia, Vereinigte Staaten, 30322
- Emory University Hospital
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Atlanta, Georgia, Vereinigte Staaten, 30033
- Atlanta VA Medical Center
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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, angiotensin-converting enzyme (ACE) inhibitors, or angiotensin receptor blocker doses
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: Fallkontrolle
- Zeitperspektiven: Interessent
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
Angiography
Patients undergoing coronary angiography without percutaneous coronary angioplasty
|
Angiography is an imaging technique to see coronary blood vessels.
|
|
Percutaneous Coronary Angioplasty
Patients with stable coronary artery disease undergoing 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in endothelial progenitor cells colony forming units
Zeitfenster: 24 hours, 1 week, and 1 month after the procedure
|
Activity of endothelial progenitor cells will be assessed in participants following their procedures.
|
24 hours, 1 week, and 1 month after the procedure
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in clinical outcomes of coronary artery disease
Zeitfenster: Up to 5 years
|
Participants will be contacted (or medical records will be examined) and asked if they have experienced cardiovascular disease outcomes such as myocardial infarction, stroke, hospitalization, coronary or peripheral revascularization, congestive heart failure exacerbation, or death.
|
Up to 5 years
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Kreton Mavromatis, MD, Emory University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- IRB00045878
Plan für individuelle Teilnehmerdaten (IPD)
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Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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