Assessment of blood flow velocity and oximetry using non-invasive retinal and cutaneous microcirculation imaging in sickle cell disease (SCD) patients and healthy volunteers. - Measurements of bloodflow in sickle cell patients and healthy volunteers.

Centre for Human Drug Research0 个研究点目标入组 28 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•Inclusion criteria
•Sickle cell disease patients
•1. Male or female subjects, 18-65 years of age, inclusive;
•2. Moderate to severe SCD with a history of at least 4 vaso-occlusive crises in total and at least 1 vaso-occlusive crisis in the last 12 months;;Healthy volunteers
•1. Healthy subjects, as defined by the absence of evidence of any active or chronic disease following a medical and surgical history, a physical examination including vital signs.
•2. Matched to sickle cell disease patients for gender, age (± 5 years), ethnicity, smoking behavior and body mass index (±3 kg/m2).

•Sickle cell disease patients
•1. History or symptoms of any significant disease including (but not limited to), neurological, psychiatric, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorder, excluding SCD and conditions that are related to SCD.
•2. Recent occurrence (<1 week preceding study day) of a vaso-occlusive crisis, defined as the need to be admitted to the hospital or to receive supportive treatment.
•3. Recent transfusion therapy (<3 weeks preceding study day).
•4. Systolic blood pressure (SBP) greater than 140 or less than 90 mm Hg, and diastolic blood pressure (DBP) greater than 90 or less than 50 mm Hg.
•5. Concomitant disease or condition that could interfere with the conduct of the study or the study objectives.
•(see protocol);Healthy volunteers
•1. History or symptoms of any significant disease including (but not limited to), neurological, psychiatric, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorder.
•2. Systolic blood pressure (SBP) greater than 140 or less than 90 mm Hg, and diastolic blood pressure (DBP) greater than 90 or less than 50 mm Hg.
•3. Concomitant disease or condition that could interfere with the conduct of the study or the study objectives, or that would, in the opinion of the Investigator, pose an unacceptable risk to the study participant.*

发起方