- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00001622
Study of the Response of Human Small Blood Vessels
Study of the Relation Between In Vivo and In Vitro Response of Human Small Vessels
A layer of cells called the endothelium line the walls of blood vessels. These cells produce substances that control the tone of blood vessels and thus control blood flow through the vessel. One of the substances produced involved in the control of blood vessel function is nitric oxide. Nitric oxide (NO) plays a role in the relaxation of blood vessels.
Researchers have been interested in the function of the endothelium in patients with high blood pressure (essential hypertension) and patients with high cholesterol (hypercholesterolemia).
After conducting studies on the endothelium and nitric oxide, researchers have found that the endothelium is indeed functioning abnormally in patients with high blood pressure and high cholesterol. In addition, researchers have determined that the dysfunction is a result of abnormalities in the nitric oxide (NO) system.
In this study researchers plan to investigate the relationship between blood vessel responses in real-life settings versus laboratory settings in normal volunteers, patients with high blood pressure, and patients with high cholesterol.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Iscrizione
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
-
-
Maryland
-
Bethesda, Maryland, Stati Uniti, 20892
- National Heart, Lung and Blood Institute (NHLBI)
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Patients (men and nonpregnant women) with systemic hypertension, patients with hypercholesterolemia, and normal volunteers.
All blood pressure recordings must be consistently elevated.
No renovascular hypertension or other etiologies for elevated blood pressure.
No definite evidence of accelerated or malignant hypertension (diastolic pressures above 115 mmHg, with associated encephalopathic changes, papilledema, progressive renal failure, or congestive heart failure), or serious intercurrent illness.
Patients in whom withdrawal of antihypertensive medications is considered hazardous are ineligible.
Patients in whom the blood pressure remains at normal levels 2 weeks after withdrawal of antihypertensive treatment will be closely monitored until they become hypertensive, at which time they will undergo the study. Patients in whom blood pressure does not increase after 2 months of discontinuation of therapy will be excluded from the study.
Patients with coexistent hypertension and hypercholesterolemia are ineligible.
Normal volunteers who are not taking any kind of medication are eligible.
No history of diabetes, peripheral vascular disease, coagulopathy, or any other disease predisposing to vasculitis or Raynaud's phenomenon.
No history of keloid formation.
All patients must be capable of giving informed consent for all procedures.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
Collaboratori e investigatori
Pubblicazioni e link utili
Pubblicazioni generali
- Furchgott RF. Role of endothelium in responses of vascular smooth muscle. Circ Res. 1983 Nov;53(5):557-73. doi: 10.1161/01.res.53.5.557. No abstract available.
- Falloon BJ, Heagerty AM. In vitro perfusion studies of human resistance artery function in essential hypertension. Hypertension. 1994 Jul;24(1):16-23. doi: 10.1161/01.hyp.24.1.16.
- Goode GK, Heagerty AM. In vitro responses of human peripheral small arteries in hypercholesterolemia and effects of therapy. Circulation. 1995 Jun 15;91(12):2898-903. doi: 10.1161/01.cir.91.12.2898.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 970098
- 97-H-0098
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .