Skip to main content
OpenTrials
Completed

NCT Number: NCT01602809

Microvessels and Heart Problems 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sickle Cell Disease Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

Primary outcomes

  1. 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...

Secondary outcomes

  1. To determine whether MBF and CBV worsen during pain crisis in patients with SCD

  2. To determine the relation between MBF and CBV and brachial artery flow or LV dysfunction.

Sponsors and collaborators

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Nih

Registry information

Official study title

Microvascular and Cardiac Dysfunction in Sickle Cell Disease

Important dates

Study start
2012
Study completion
2017
First posted
May 21, 2012
Registry last updated
Oct 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.