Early Diagnosis of Sickle Acute Chest Syndrome Using a Combination of Plasma Bimarkers and Chest Imaging
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Anemia |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 10 - 85 |
| Updated: | 4/6/2019 |
| Start Date: | April 10, 2019 |
| End Date: | December 31, 2020 |
Early Diagnosis of Sickle Acute Chest Syndrome Using a Combination of Plasma Biomarkers and Chest Imaging
Background:
Painful vasoocclusive crisis (VOC) occurs in people with sickle cell disease (SCD). People
with VOC have many visits to the hospital. About 10 30 percent of these people will go on to
develop acute chest syndrome (ACS). ACS can cause further ill health. It can also cause
death. Researchers want to find ways to diagnose ACS more quickly. To do this, they want to
use stored blood samples and scans from a study (the DeNOVO trial) that was closed in 2015.
They want to see if scans and samples taken of people with VOC who later developed ACS could
help diagnose ACS faster. The data of people in the DeNOVO study who did not develop ACS will
serve as controls.
Objectives:
To look at data from the DeNOVO trial to find a way to diagnose ACS more quickly.
Eligibility:
People 10 85 years old who took part in NHLBI Protocol number 05-H-0019 (the DeNOVO trial).
The trial lasted from 2004 to 2008. The study was closed in November 2015.
Design:
Scans and intact, frozen samples from a study that was closed in 2015 will be studied. No new
participants will be enrolled.
Painful vasoocclusive crisis (VOC) occurs in people with sickle cell disease (SCD). People
with VOC have many visits to the hospital. About 10 30 percent of these people will go on to
develop acute chest syndrome (ACS). ACS can cause further ill health. It can also cause
death. Researchers want to find ways to diagnose ACS more quickly. To do this, they want to
use stored blood samples and scans from a study (the DeNOVO trial) that was closed in 2015.
They want to see if scans and samples taken of people with VOC who later developed ACS could
help diagnose ACS faster. The data of people in the DeNOVO study who did not develop ACS will
serve as controls.
Objectives:
To look at data from the DeNOVO trial to find a way to diagnose ACS more quickly.
Eligibility:
People 10 85 years old who took part in NHLBI Protocol number 05-H-0019 (the DeNOVO trial).
The trial lasted from 2004 to 2008. The study was closed in November 2015.
Design:
Scans and intact, frozen samples from a study that was closed in 2015 will be studied. No new
participants will be enrolled.
Painful vasoocclusive crisis (VOC) is the most frequent acute clinical manifestation of
sickle cell disease (SCD), frequently necessitating emergency department visits and/or
hospitalization. Approximately 10-30% of patients admitted to the hospital with a VOC will go
on to develop acute chest syndrome (ACS), a complication of SCD resulting in significant
morbidity and mortality. While ACS related mortality appears to be improving in the United
States, the number of hospital admissions for ACS is on the rise. Unfortunately, the
diagnosis of ACS is often delayed with up to 50% of cases diagnosed two to three days after
an admission for VOC. The clinical diagnosis of ACS is often delayed as it mimics other
respiratory diseases. Furthermore, the lack of definitive laboratory and radiological
biomarkers further confounds the ability to detect rapidly progressive ACS, a phenotype
accounting for considerable ACS-related mortality. Currently, a key criterion for the
diagnosis of ACS is the presence of new airspace disease on a chest radiograph in a sickle
cell patient with respiratory symptoms. However, the appearance of abnormalities on chest
radiography (CXR) often lags behind clinical signs and diagnostic techniques such as computed
tomography (CT) which tends to reveal radiologic changes much earlier than CXR. Early
diagnosis and treatment of ACS improves outcomes, hence the scientific rationale to perform
such studies and develop diagnostic algorithms to facilitate early detection of ACS.
In the current study proposal, we will utilize stored blood samples and review CT scans and
CXRs from 65 participants of the DeNOVO trial (NHLBI protocol # 05-H-0019). This multicenter
trial conducted between 2004-08 at 11 centers including the NIH, showed that among patients
with SCD hospitalized with VOC, the use of inhaled nitric oxide compared with placebo did not
improve time to crisis resolution. In this study, patients enrolled at the NIH study site had
baseline admission research blood drawn and thoracic CT scans performed. A repeat CT scan and
repeat blood work was subsequently obtained during the development of ACS. The archived data
from this subset of the study cohort therefore provides an opportunity to rigorously test the
hypothesis that CT scans performed early in the setting of VOC in patients going on to
develop ACS would have utility in the rapid diagnosis of this condition. Furthermore, the
availability of stored plasma samples from this cohort permits the study of both imaging and
plasma biomarkers in a prospectively defined sample of SCD patients. Specifically, we will
identify patients admitted with VOC that went on to develop ACS and study their CT scans and
plasma to determine whether these biomarkers will rapidly diagnose ACS. The patients in the
same study who did not develop ACS will serve as controls.
sickle cell disease (SCD), frequently necessitating emergency department visits and/or
hospitalization. Approximately 10-30% of patients admitted to the hospital with a VOC will go
on to develop acute chest syndrome (ACS), a complication of SCD resulting in significant
morbidity and mortality. While ACS related mortality appears to be improving in the United
States, the number of hospital admissions for ACS is on the rise. Unfortunately, the
diagnosis of ACS is often delayed with up to 50% of cases diagnosed two to three days after
an admission for VOC. The clinical diagnosis of ACS is often delayed as it mimics other
respiratory diseases. Furthermore, the lack of definitive laboratory and radiological
biomarkers further confounds the ability to detect rapidly progressive ACS, a phenotype
accounting for considerable ACS-related mortality. Currently, a key criterion for the
diagnosis of ACS is the presence of new airspace disease on a chest radiograph in a sickle
cell patient with respiratory symptoms. However, the appearance of abnormalities on chest
radiography (CXR) often lags behind clinical signs and diagnostic techniques such as computed
tomography (CT) which tends to reveal radiologic changes much earlier than CXR. Early
diagnosis and treatment of ACS improves outcomes, hence the scientific rationale to perform
such studies and develop diagnostic algorithms to facilitate early detection of ACS.
In the current study proposal, we will utilize stored blood samples and review CT scans and
CXRs from 65 participants of the DeNOVO trial (NHLBI protocol # 05-H-0019). This multicenter
trial conducted between 2004-08 at 11 centers including the NIH, showed that among patients
with SCD hospitalized with VOC, the use of inhaled nitric oxide compared with placebo did not
improve time to crisis resolution. In this study, patients enrolled at the NIH study site had
baseline admission research blood drawn and thoracic CT scans performed. A repeat CT scan and
repeat blood work was subsequently obtained during the development of ACS. The archived data
from this subset of the study cohort therefore provides an opportunity to rigorously test the
hypothesis that CT scans performed early in the setting of VOC in patients going on to
develop ACS would have utility in the rapid diagnosis of this condition. Furthermore, the
availability of stored plasma samples from this cohort permits the study of both imaging and
plasma biomarkers in a prospectively defined sample of SCD patients. Specifically, we will
identify patients admitted with VOC that went on to develop ACS and study their CT scans and
plasma to determine whether these biomarkers will rapidly diagnose ACS. The patients in the
same study who did not develop ACS will serve as controls.
- Patients (aged 10 years and older) presenting with vaso-occlusive crisis requiring
admission that were enrolled in the DeNOVO study specifically at the NIH clinical
center (n=65).We will use stored blood
samples and review radiological images from these patients.
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