Microvessels and Heart Problems in Sickle Cell Disease
26 octobre 2017 mis à jour par: National Heart, Lung, and Blood Institute (NHLBI)
Microvascular and Cardiac Dysfunction in Sickle Cell Disease
Background:
- Small blood vessels (microvessels) in many different organs are affected by diseases such as diabetes and atherosclerosis. These microvessels may also be abnormal in people who have sickle cell disease. Stiffness of the red blood cells leads to problems in the microvessels of the heart and kidneys. However, these problems may not be detected until these organs are severely affected. Researchers want to study problems with microvessels in people with and without sickle cell disease.
Objectives:
- To study how microvessels in the heart and other organs are affected by sickle cell disease.
Eligibility:
- Individuals at least 18 years of age who have sickle cell disease.
- Healthy volunteers at least 18 years of age.
Design:
- Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected.
- All participants will have about 3 to 4 hours of testing for the study. Participants with sickle cell disease who are having a pain crisis at the time they enter the study may be asked to have the testing again when the crisis is over. The repeat testing will occur at least 4 weeks after the pain crisis ends.
- All participants will have the following tests:
- Blood draws to check kidney and liver function, and other blood tests
- Measure of blood flow in the brachial (upper arm) artery
- Heart ultrasound
- Ultrasound scans of arm muscles to study blood flow
- Ultrasound scans after taking vasodilators to increase blood flow
- Healthy volunteers will also have a magnetic resonance imaging scan. It will show blood flow in the heart. This scan will involve another dose of a vasodilator.
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
Sickle cell disease is the most common genetic disease affecting African-Americans.
It is characterized by an abnormal hemoglobin S, which polymerizes when deoxygenated leading to red cell rigidity and microvascular flow obstruction.
Recurrent episodes of ischemia and a chronic inflammatory state lead to ischemia-reperfusion injury in multiple vital organ systems.
Endothelial dysfunction has been demonstrated in patients with sickle cell disease and new therapies are targeted specifically towards the endothelium.
Contrast ultrasound is a non-invasive technique that has been used to assess microvascular flow in coronary artery disease, diabetes, and other disease states.
We propose to use this technique in sickle cell patients to compare their myocardial and skeletal muscle flow with that of normal controls, to detect changes during pain crisis, and to compare flow abnormalities with cardiac functional abnormalities.
Type d'étude
Observationnel
Inscription (Réel)
65
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Maryland
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Bethesda, Maryland, États-Unis, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
- INCLUSION CRITERIA:
- Adult subject age greater than or equal to 18 years
- Able to give written informed consent
- For SCD groups, must have confirmed diagnosis of sickle cell disease
EXCLUSION CRITERIA:
- Atrial fibrillation or other irregular rhythm that would preclude adequate image acquisition
- Subjects with a contraindication for the ultrasound contrast agent.
- Pregnant or lactating women
- Known obstructive coronary or peripheral vascular disease
- SCD subjects at steady-state must not have acute pain crisis requiring intravenous analgesics within the prior 4 weeks
- SCD subjects in crisis must be within 72 hours of hospital admission
- Subjects with contraindications to MRI scanning will complete all other procedures but will not undergo the MRI scan. Subjects with an estimated glomerular filtration rate of <30 ml/min/1.73 m(2) will not receive gadolinium as per 2011 NHLBI gadolinium administration policy.
- Subjects with a contraindication to regadenson
- Any condition that in the clinical opinion of the investigators renders study procedures inadvisable.
Diagnosis of acute chest syndrome is not an exclusion criteria for this protocol. Subjects may be concurrently enrolled in any other protocols with the exception of investigational new drug studies.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Perspectives temporelles: Éventuel
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
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To use contrast-enhanced ultrasound to evaluate microvascular blood flow (MBF) and capillary RBC velocity (CBV) in skeletal muscle and the heart (at rest and during vasodilator stress) in patients with SCD in comparison to normal control patient...
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Mesures de résultats secondaires
Mesure des résultats |
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To determine whether MBF and CBV worsen during pain crisis in patients with SCD
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To determine the relation between MBF and CBV and brachial artery flow or LV dysfunction.
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Les enquêteurs
- Chercheur principal: Vandana Sachdev, M.D., National Heart, Lung, and Blood Institute (NHLBI)
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Kato GJ, Hebbel RP, Steinberg MH, Gladwin MT. Vasculopathy in sickle cell disease: Biology, pathophysiology, genetics, translational medicine, and new research directions. Am J Hematol. 2009 Sep;84(9):618-25. doi: 10.1002/ajh.21475.
- Hebbel RP, Osarogiagbon R, Kaul D. The endothelial biology of sickle cell disease: inflammation and a chronic vasculopathy. Microcirculation. 2004 Mar;11(2):129-51.
- Morris CR, Kuypers FA, Larkin S, Vichinsky EP, Styles LA. Patterns of arginine and nitric oxide in patients with sickle cell disease with vaso-occlusive crisis and acute chest syndrome. J Pediatr Hematol Oncol. 2000 Nov-Dec;22(6):515-20. doi: 10.1097/00043426-200011000-00009.
- Sachdev V, Sidenko S, Wu MD, Minniti CP, Hannoush H, Brenneman CL, Waclawiw MA, Arai AE, Schechter AN, Kato GJ, Lindner JR. Skeletal and myocardial microvascular blood flow in hydroxycarbamide-treated patients with sickle cell disease. Br J Haematol. 2017 Nov;179(4):648-656. doi: 10.1111/bjh.14918. Epub 2017 Sep 7.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
30 avril 2012
Achèvement de l'étude
25 octobre 2017
Dates d'inscription aux études
Première soumission
18 mai 2012
Première soumission répondant aux critères de contrôle qualité
18 mai 2012
Première publication (Estimation)
21 mai 2012
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
27 octobre 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
26 octobre 2017
Dernière vérification
25 octobre 2017
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 120124
- 12-H-0124
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