Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06372730
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-03-11
Brief Title:
Residual Pulmonary Vascular Obstruction Index Computed With VentilationPerfusion SPECTCT Imaging to Predict the Risk of Venous Thromboembolism Recurrence in Patients With Pulmonary Embolism PRONOSPECT
Sponsor:
University Hospital Brest
Organization:
University Hospital Brest
Study Overview
Official Title:
Residual Pulmonary Vascular Obstruction RPVO Index Computed With VentilationPerfusion SPECTCT Imaging to Predict the Risk of Venous Thromboembolism VTE Recurrence in Patients With Pulmonary Embolism PE
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
PRONOSPECT
Brief Summary:
Major risk after pulmonary embolism PE is recurrence fatal in 10 of patients Patients with PE can be stratified in 3 groups according to the risk of recurrence very low risk high risk or Intermediate risk Little is known about this last group
Anticoagulation is efficient to prevent recurrence but is currently not recommended for patient with an intermediate risk of recurrence
Identifying risk factors of recurrent PE remains a major issue to identify sub-groups of patients who would require lifelong anticoagulation
In 30-40 of cases PE patients develop residual pulmonary vascular obstruction RPVO which has been found to be associated with an increased recurrence risk This last observation was mostly reported in patients with unprovoked PE patients with high risk of recurrence and RPVO was measured using conventional planar lung scan
In patients with an intermediate risk of recurrence the impact of RPVO has been much less studied In addition the definition of RPVO was variable according to studies and correlation between RPVO burden and recurrence risk has not been clearly demonstrated This might be explained by the inherent limitation of RPVO quantification using conventional planar imaging which is only based on a visual estimation on 2-dimensional images
VentilationPerfusion Single Photon Emission Computed Tomography VQ SPECTCT is a new method of scintigraphic image acquisition that offers the advantage of 3-dimensional imaging enabling more accurate and reproducible quantification of RPVO
The main hypothesis of this study is that in patients with PE at intermediate risk of recurrence RPVO computed with VQ SPECTCT imaging may be an important predictor of recurrence
Anticoagulation is efficient to prevent recurrence but is currently not recommended for patient with an intermediate risk of recurrence
Identifying risk factors of recurrent PE remains a major issue to identify sub-groups of patients who would require lifelong anticoagulation
In 30-40 of cases PE patients develop residual pulmonary vascular obstruction RPVO which has been found to be associated with an increased recurrence risk This last observation was mostly reported in patients with unprovoked PE patients with high risk of recurrence and RPVO was measured using conventional planar lung scan
In patients with an intermediate risk of recurrence the impact of RPVO has been much less studied In addition the definition of RPVO was variable according to studies and correlation between RPVO burden and recurrence risk has not been clearly demonstrated This might be explained by the inherent limitation of RPVO quantification using conventional planar imaging which is only based on a visual estimation on 2-dimensional images
VentilationPerfusion Single Photon Emission Computed Tomography VQ SPECTCT is a new method of scintigraphic image acquisition that offers the advantage of 3-dimensional imaging enabling more accurate and reproducible quantification of RPVO
The main hypothesis of this study is that in patients with PE at intermediate risk of recurrence RPVO computed with VQ SPECTCT imaging may be an important predictor of recurrence
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-A01566-39 | OTHER | IDRCB | None |