Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2025-12-28 @ 7:42 AM
Study NCT ID:
NCT05073666
Status:
COMPLETED
Last Update Posted:
2025-03-06
First Post:
2021-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence and Risk Factors of Chronic Thrombo-embolic Disease After a Pulmonary Embolism Event
Sponsor:
Centre Hospitalier Universitaire de Nice
Organization:
Study Overview
Official Title:
Prevalence and Risk Factors of Chronic Thrombo-embolic Disease After a Pulmonary Embolism Event The PACTE Registry
Status:
COMPLETED
Status Verified Date:
2025-03
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:
PACTE
Brief Summary:
Venous thromboembolic disease (VTE) is a common clinical entity whose two manifestations are deep vein thrombosis (DVT) and pulmonary embolism (PE). After an acute PE, almost half of the patients complain residual dyspnea, despite well-conducted curative anticoagulation. Some will present persistent defects on lung scan-scintigraphy, without pulmonary hypertension. This condition defines Chronic-Thrombo-Embolic Disease(CTED). The prevalence of CTED after PE is poorly known as are its risk factors.
The primary objective is to determine the prevalence of CTED at 3 or 6 months, depending on the provoked or unprovoked character, after a PE.
The secondary objectives are:
* To determine the potential risk factors for the occurrence of CTED.
* To look for an association between the persistence of DVT and the occurrence of CTED.
* To look for an association between the diagnosis of CTED and PE recurrence during the 12-month follow-up.
* To determine the diagnostic performance of the clinician alone compared to the lung scintigraphy (gold standard) for the diagnosis of CTED.
* To compare the impact on the quality of life (QoL) with or without CTED.
* To determine the correlation between impaired QoL and the degree of residual obstruction on lung scintigraphy.
The primary objective is to determine the prevalence of CTED at 3 or 6 months, depending on the provoked or unprovoked character, after a PE.
The secondary objectives are:
* To determine the potential risk factors for the occurrence of CTED.
* To look for an association between the persistence of DVT and the occurrence of CTED.
* To look for an association between the diagnosis of CTED and PE recurrence during the 12-month follow-up.
* To determine the diagnostic performance of the clinician alone compared to the lung scintigraphy (gold standard) for the diagnosis of CTED.
* To compare the impact on the quality of life (QoL) with or without CTED.
* To determine the correlation between impaired QoL and the degree of residual obstruction on lung scintigraphy.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: