Atrial Fibrillation Clinical Trial
— FAPSVerified date | February 2022 |
Source | University Hospital, Bordeaux |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Arterial thromboembolism constitutes a major risk of atrial fibrillation (AF) requiring antithrombotic therapy. Platelets and microparticles (MPs) are important for hemostasis and thrombosis, their role during AF is not well known. The principal objective of this study is to compare morphologic, functional and proteomics characteristics of blood platelet between AF patients and healthy volunteers.
Status | Terminated |
Enrollment | 86 |
Est. completion date | October 26, 2018 |
Est. primary completion date | October 26, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Inclusion Criteria: valid for all groups - Age superior or equal to 18 years old, both genders. - Patient affiliated or recipient of a social welfare regimen. - Patient's write agreement for study participation after reading information note - Inclusion Criteria: specific for groups Group 1: - Volunteers without heart disease. - Volunteers who never had AF and not in AF the day of inclusion. Group 2 - Patient suffering of paroxysmal atrial fibrillation since at least 6 month and addressed for primo ablation of atrial fibrillation. - Patient in sinus rhythm the day of inclusion. Group 3 - Patient suffering of paroxysmal atrial fibrillation since at least 6 month and addressed for primo ablation of atrial fibrillation. - Patient in atrial fibrillation the day of inclusion Group 4 - Patient suffering of persistent atrial fibrillation since at least 6 month and addressed for primo ablation of atrial fibrillation. - Patient in sinus rhythm the day of inclusion. Group 5 - Patient suffering of persistent atrial fibrillation since at least 6 month and addressed for primo ablation of atrial fibrillation. - Patient in atrial fibrillation the day of inclusion Exclusion Criteria: - Age <18 years. - Active smoker (> 10 cigarettes/days) - Pregnant woman or breastfeeding women or not receiving effective contraception. - Volunteer participating in another interventional study requiring taking drug. - Volunteer having taken antinflammatory, platelet anti-aggregant or calcium-channel blocker drugs within 8 days prior to inclusion - Valvular heart diseases. - Chronic inflammatory diseases. - Cardiovascular event or stroke within 3 month prior to inclusion - Uncontrolled hypertension - Chronic hepatic or renal diseases. |
Country | Name | City | State |
---|---|---|---|
France | Service d'Electrophysiologie et de stimulation cardiaque / LIRYC - Hôpital Cardiologique du Haut Lévêque | Pessac |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Bordeaux |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Measure of maximal aggregation level (expressed in aggregation percentage) after ex vivo stimulation by Adenosine Di-Phosphate (ADP), arachidonic acid, ristocetin, collagen and Thrombin Receptor Activating Peptide (TRAP-6mers) | Aggregation percentage is measured by the method of light transmission aggregometry | Day 1 | |
Primary | Measure of maximal disaggregation level (expressed in disaggregation percentage) | Disaggregation percentage is measured by the method of light transmission aggregometry | Day 1 | |
Primary | Measure of platelet volume mean | Day 1 | ||
Primary | Assessment of the Platelet morphology (shape change) | Day 1 | ||
Primary | Assessment of the modification of the membrane receptor expression modification | Day 1 | ||
Primary | Identification of platelet proteins differentially expressed between groups | Day 1 | ||
Secondary | Measure of Tissue Factor (TF) dependent microparticles level | Day 1 | ||
Secondary | Measure of fibrinolytic microparticles level | Day 1 |
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