Back to resultsIs Clonal Hematopoiesis of Indeterminate Potential Associated With Unprovoked Pulmonary Embolism? (HEMEP)
Primary Purpose
Pulmonary Embolism, Hematopoiesis
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood sample
Sponsored by
About this trial
This is an interventional basic science trial for Pulmonary Embolism focused on measuring Pulmonary Embolism, hematopoiesis, genetic sequencing, endothelial dysfunction
Eligibility Criteria
Inclusion Criteria:
- For cases : Previous proximal unprovoked pulmonary embolism, negative thrombophilia screening.
- For control : Previous proximal provoked pulmonary embolism, negative thrombophilia screening.
Exclusion Criteria:
- Age superior to 65 years old,
- Active cancer
Sites / Locations
- CHU AmiensRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Previous proximal unprovoked pulmonary embolism
Previous proximal provoked pulmonary embolism
Arm Description
Outcomes
Primary Outcome Measures
Variation of CHIP markers between patients groups
Variation of CHIP markers (clonal hematopoiesis of indetermined prognosis ) between patients groups.
CHIP concept have been defined as a mutation of preleukemic genes at an allelic variation inferior to 2% associated with normal complete blood count.
Secondary Outcome Measures
Full Information
NCT ID
NCT04711746
First Posted
January 13, 2021
Last Updated
February 7, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT04711746
Brief Title
Is Clonal Hematopoiesis of Indeterminate Potential Associated With Unprovoked Pulmonary Embolism?
Acronym
HEMEP
Official Title
Is Clonal Hematopoiesis of Indeterminate Potential Associated With Unprovoked Pulmonary Embolism?
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The clonal hematopoiesis of indetermined prognosis (CHIP) has been described as risk factor for juvenile atherosclerosis. Moreover, some of CHIP genes are responsible of myeloproliferative disorders. Venous thrombosis are frequent in these disorders. The purpose of this project is to determine if CHIP is frequent in unprovoked pulmonary embolism and could be part of the pathophysiology.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism, Hematopoiesis
Keywords
Pulmonary Embolism, hematopoiesis, genetic sequencing, endothelial dysfunction
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
544 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Previous proximal unprovoked pulmonary embolism
Arm Type
Experimental
Arm Title
Previous proximal provoked pulmonary embolism
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
blood sample
Intervention Description
Blood sample withdrawal in order to perform DNA sequencing
Primary Outcome Measure Information:
Title
Variation of CHIP markers between patients groups
Description
Variation of CHIP markers (clonal hematopoiesis of indetermined prognosis ) between patients groups.
CHIP concept have been defined as a mutation of preleukemic genes at an allelic variation inferior to 2% associated with normal complete blood count.
Time Frame
up to 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
For cases : Previous proximal unprovoked pulmonary embolism, negative thrombophilia screening.
For control : Previous proximal provoked pulmonary embolism, negative thrombophilia screening.
Exclusion Criteria:
Age superior to 65 years old,
Active cancer
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Simon SOUDET, MD
Phone
03 22 88 72 89
Email
soudet.simon@chu-amiens.fr
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80480
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SOUDET Simon, MD
Phone
03 22 88 72 89
Email
soudet.simon@chu-amiens.fr
12. IPD Sharing Statement
Plan to Share IPD
No
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Is Clonal Hematopoiesis of Indeterminate Potential Associated With Unprovoked Pulmonary Embolism?
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