Assessment of the cutaneous and retinal microcirculation in SCD patients and matched controls:- Long- and short-term repeatability of LSCI and NiRFI ;- Comparison of cutaneous and retinal microcirculation between SCD patients and matched healthy…
ID
Source
Brief title
Condition
- Anaemias nonhaemolytic and marrow depression
- Blood and lymphatic system disorders congenital
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Retinal blood flow by NiRFI:
- blood flow velocity
- capillary perfusion maps and microvasculature enhancement
- blood oximetry
- metabolic intrinsic state/function
Cutaneous microvascular blood flow by LSCI:
- basal blood flow
- flow upon occlusion-reperfusion
- blood flow upon inspiratory breath holding
Secondary outcome
Not applicable
Background summary
Peripheral vascular dysfunction has often been observed in Sickle Cell Disease
(SCD) patients. The progression of the disease and the risk of complications
can be monitored by assessment of the vascular function. However, the
methodology used to assess microvascular function is not uniform, rarely
validated and the feasibility unknown. This results in a paucity of data of the
appropriate methodology to assess the natural course of microvascular
abnormalities and impairs the possibilities to reliably measure possible
treatment effects in clinical trials. This project aims to assess the
feasibility of three new devices for measurement of the microvasculature in SCD
patients, laser speckle contrast imaging and non-invasive retinal function
imaging (LSCI and NiRFI).
Study objective
Assessment of the cutaneous and retinal microcirculation in SCD patients and
matched controls:
- Long- and short-term repeatability of LSCI and NiRFI ;
- Comparison of cutaneous and retinal microcirculation between SCD patients and
matched healthy volunteers;
- The effect of occlusion-reperfusion of the brachial artery and inspiratory
breath hold on cutaneous blood flow as assessed by LSCI.
Study design
Open observational single center study in SCD patients and matched healthy
volunteers.
- two study days separated by one week
- assessment of cutaneous and retinal microcirculation by LSCI and NiRFI
- two assessments blocks per study day, separated by 1 hour
Study burden and risks
This is an observational study without pharmacological intervention. The main
intervention that the study participants will undergo is assessment of vascular
function by LSCI and NiRFI, which are all non-invasive methods. In addition,
the cutaneous microcirculation will be assessed after occlusion-reperfusion of
the brachial artery, and after respiratory manipulation (inspiratory breath
holding). These interventions are commonly applied in human studies on vascular
functionality, and the risk for the study participants is negligible. Further,
study participants will be studied in a state-of the-art clinical unit and
medically supervised by qualified medical staff.
Zernikedreef 8
Leiden 2333CL
NL
Zernikedreef 8
Leiden 2333CL
NL
Listed location countries
Age
Inclusion criteria
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).
Exclusion criteria
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.*
Design
Recruitment
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL49940.058.14 |