Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005326
Status:
COMPLETED
Last Update Posted:
2016-03-16
First Post:
2000-05-25
Brief Title:
Cerebrovascular Involvement in Sickle Cell Disease - Comprehensive Sickle Cell Center
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2004-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To continue studies on the two major neurological complications of sickle cell disease SCD namely stroke and chronic encephalopathy
Detailed Description:
BACKGROUND
Stroke represents a focal brain insult whereas chronic encephalopathy represents a diffuse brain disturbance involving cognition and memory The predisposition to stroke and the potential for dementia were increasingly apparent from our studies and the work of other investigators in sickle cell disease The ontogeny of these two processes required further study before the mechanisms could be clearly articulated and a coordinated assessment of cerebrovascular perfusion was needed to decipher the relationship between focal perfusion deficits and occlusion of large and small cerebral vessels 150 subjects were enrolled in these studies Improved understanding of the mechanisms underlying these two devastating neurological complications of SCD should result in prevention or effective treatment
DESIGN NARRATIVE
Three hypotheses were tested 1 clinically-silent cranial magnetic resonance imaging MRI abnormalities represented the minimal expression of the neurovascular diathesis and were the harbingers of clinically-overt strokes study A 2 sickle cell disease patients who developed cerebral infarctions had a predisposing risk factors that contributed to this neurological complication study B and 3 sickle cell disease patients developed a chronic encephalopathy and dementia that was independent of the neurovascular diathesis study C Study A was a prospective evaluation of 50 SCD children aged 6 to 12 years attempting to identify a subgroup of patients at risk for the development of a clinically-apparent stroke These patients were evaluated clinically and underwent MRI scan magnetic resonance angiography MRA and single photon emission computerized tomography SPECT Study B represented two studies designed to analyze risk factors for stroke The first study was a retrospective case-control analysis of 25 young adults who suffered one or more strokes These patients were age-matched to an SCD control group which had been clinically free of strokes and had MRI MRA and SPECT studies The second study represented a prospective case-control analysis of children who were being followed in study A Study C represented a prospective study of 50 SCD children and 50 age-matched siblings or closest available relatives Annual neurological examinations and neuropsychological evaluations were performed searching for evidence of chronic encephalopathy and dementia The longitudinal study design was necessary to dissect out the subtle variables that contributed to the cognitive deficits The study was renewed in FY 1998 to continue through FY 2004
Note Darryl DeVivo was PI on Subproject which began in FY 1988 as a competing renewal The total grant began several years prior to that Dollars for the subproject were estimated at 10 of the total funds awarded each year
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Stroke represents a focal brain insult whereas chronic encephalopathy represents a diffuse brain disturbance involving cognition and memory The predisposition to stroke and the potential for dementia were increasingly apparent from our studies and the work of other investigators in sickle cell disease The ontogeny of these two processes required further study before the mechanisms could be clearly articulated and a coordinated assessment of cerebrovascular perfusion was needed to decipher the relationship between focal perfusion deficits and occlusion of large and small cerebral vessels 150 subjects were enrolled in these studies Improved understanding of the mechanisms underlying these two devastating neurological complications of SCD should result in prevention or effective treatment
DESIGN NARRATIVE
Three hypotheses were tested 1 clinically-silent cranial magnetic resonance imaging MRI abnormalities represented the minimal expression of the neurovascular diathesis and were the harbingers of clinically-overt strokes study A 2 sickle cell disease patients who developed cerebral infarctions had a predisposing risk factors that contributed to this neurological complication study B and 3 sickle cell disease patients developed a chronic encephalopathy and dementia that was independent of the neurovascular diathesis study C Study A was a prospective evaluation of 50 SCD children aged 6 to 12 years attempting to identify a subgroup of patients at risk for the development of a clinically-apparent stroke These patients were evaluated clinically and underwent MRI scan magnetic resonance angiography MRA and single photon emission computerized tomography SPECT Study B represented two studies designed to analyze risk factors for stroke The first study was a retrospective case-control analysis of 25 young adults who suffered one or more strokes These patients were age-matched to an SCD control group which had been clinically free of strokes and had MRI MRA and SPECT studies The second study represented a prospective case-control analysis of children who were being followed in study A Study C represented a prospective study of 50 SCD children and 50 age-matched siblings or closest available relatives Annual neurological examinations and neuropsychological evaluations were performed searching for evidence of chronic encephalopathy and dementia The longitudinal study design was necessary to dissect out the subtle variables that contributed to the cognitive deficits The study was renewed in FY 1998 to continue through FY 2004
Note Darryl DeVivo was PI on Subproject which began in FY 1988 as a competing renewal The total grant began several years prior to that Dollars for the subproject were estimated at 10 of the total funds awarded each year
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P60HL028381 | NIH | None | httpsreporternihgovquickSearchP60HL028381 |