Research Interest Antiphospholipid in Predicting Embolic Risk During Infective Endocarditis (EMBOL-EI)
EMBOL-EI (Research Interest antiphospholipid antibody for embolic risk prediction in infective endocarditis) is a prospective cohort study with a biological collection.
The main objective is: to re-evaluate the potential value of antiphospholipid (aPL) antibodies as predictors of embolic events in infective endocarditis (IE) in the light of the improved current knowledge on these aPL.
The seconds objectives are: Other plasma biomarkers of hemostasis (coagulation activation markers: D-dimer fragment 1 + 2 of prothrombin; endothelial biomarkers: plasma levels of von Willebrand factor) will be taken into account in the analysis, and interest in predicting embolic risk, alone or in combination with aPL will be investigated.
調査の概要
状態
条件
詳細な説明
Criteria of inclusion
- Patient hospitalized in the University Hospital of Nancy with an Endocarditis some as modified Duke criteria by Li.
The patient is eligible if it is considered and treated as a case of infective endocarditis by physicians ensuring its management. The application of the diagnostic classification Duke criteria modified by Li is made after the collection of all the data at the output of the patient. Will be retained for the analysis of patients meeting certain infective endocarditis.
Clinical, microbiological data, derived from complementary therapies and scalable examinations (including the endpoint) were collected during the hospital stay by doctors that support helped a patient technician clinical studies. Each application is reviewed by a multidisciplinary panel of two experts for validation.
Once validated record, the data collection schedule is sent to the Centre d'Investigation Clinique 1433 Epidémiologie Clinique (CIC-EC) to be entered on a database.
A blood sample is taken from each patient at admission. These samples are packaged and stored in a collection. The serum used in search - called anticardiolipin (AC) Immunoglobulin G (IgG) and Immunoglobulin M (IgM) isotype by ELISA.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
-
Besancon、フランス
- CHU de Besançon
-
Nancy、フランス
- CHU de Nancy
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- All the patients admitted either in the Infectious Department, in the Cardiology Department or in the Intensive Care Unit of the University Hospital of Nancy and treated for IE.
Exclusion Criteria:
- Patients with a previously known aPL syndrome or illness frequently associated with aPL syndrome (such as lupus)
- Patients with a delay between blood sample and diagnosis of IE longer than 21days
- Patients who had no symptomatic embolic events and no imaging procedure to detect an asymptomatic embolic event
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：コホート
- 時間の展望：見込みのある
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Symptomatic or asymptomatic events occurring before and after IE diagnosis
時間枠：at discharge, an average of 8 weeks after inclusion
|
By patients have systematic extra-cardiac imaging
|
at discharge, an average of 8 weeks after inclusion
|
協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。